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We are pleased to announce that the request to extend the Flowflex ACON Laboratories, Inc., has become aware that counterfeit versions of its FDA-authorized Flowflex COVID-19 Antigen Home Tests in the 1 Test/ kit box configuration marked as Lot# COV2010030 and COV2030016 are being illegally distributed in the United States through For more information on EUAs please visit: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, For the most up to date information on COVID-19, please visit: www.cdc.gov/COVID19, Terms and ConditionsTerms of Use Privacy Policy, 2022 ACON Laboratories, Inc. 10125 Mesa Rim Road, San Diego CA 92121. display: -ms-flexbox; @media all and (max-width: 850px) { #text-15297007 { } How To Use - Flow Flex Rapid Test How To Use Watch how to use our antigen test kit How To Use OUR Antigen Rapid Test Please take the time to watch our short video showing how to use our test kit. The test is available in 1-Pack, 2-Pack and 5-Pack. } The SARS-CoV-2 Antigen Rapid Test is a lateral flow test for the qualitative detection of the nucleocapsid antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals suspected of COVID-19 within the first seven days of the onset of symptoms. This product is temporarily unavailable online. 293 0 obj <>stream align-self: center; UK APPROVED Rapid Covid-19 Lateral Flow Antigen Test Kits, Mon - Fri: 9am - 6pm | Weekends: 10am - 4pm. This test procedure overview does not replace the package insert. FlowFlex Rapid Antigen Test Kits use new technology in detecting the important protein found in COVID-19. Some Flowflex tests aren't regulated in the US, the FDA says. Gardian T3 COVID-19-SARS-CoV-2 Antigen Saliva Self Test (pdf,691kb) While the Flowflex test that comes in a white box with the full name "Flowflex COVID-19 Antigen Home Test" is safe to use (it has an emergency use authorization from the FDA), there's a. The BinaxNOW COVID-19 test is a rapid antigen test that provides results within 15 minutes at home. Medical news, pregnancy topics and health hacks that don't cost money. If you have questions, please contact customer support at 1 (800) 838 9502. -webkit-box-pack: center; The Flowflex SARS-CoV-2 Antigen Rapid Test (self-test) is for self-testing by adults and children above the age of 14. padding: 8px 19px 7px 19px; 8 January 2022. See. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The FDA is working with ACON Laboratories, Inc. to resolve this safety issue. COVID-19 test insurance reimbursement. } Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives. } font-weight: 300; ACON released a side-by-side comparison of the two products hoping to help U.S. consumers differentiate between the recalled test and the one cleared for emergency use. Risks of. }. We've found one or more places that match your search. K proveden testu by Acon Biotech Hangzhou Flowflex SARS-CoV-2 Antigen Rapid Test 5 ks Now everyone can enjoy the family for the upcoming holidays. find out more. -webkit-box-pack: center; The FlowFlex Rapid Test Kit uses the latest patented technology in detecting proteins ensuring that it can detect new strains of the COVID-19 virus. These results have been shared with the FDA. The recall of the test, which the government estimates has 200,000 in U.S. circulation, may confuse consumers between two Flowflex branded antigen tests. Free Postage. Makes it the perfect test kit for traveling and testing on the go. border-radius: 5px; Here's a quick overview of how it works: .cu-ticker .cu-ticker--container .cu-ribbon--text { .cu-ticker .cu-ticker--container .cu-ribbon--text { Please click here to check the new expiration date using the lot number printed on the test kit box. Ensure you are aware this will not provide you with a certificate and your results will not be verified. Before CNET, she worked in local journalism covering public health issues, business and music. padding: 12px !important; For in vitro diagnostic use only. PRODUCT DETAILS. Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (pdf,975kb) (Rapid antigen test) Nasal swab. Testing for antigens is another way to determine if you contracted COVID-19, especially if you are asymptomatic. We also ask that you complete our questionnaire so our pharmacy team can check that this product is suitable for you to buy. Free Boots Vitamin D 10ug 3 month supply when you buy selected healthcare or wellness products - online only, whilst stocks last, Boots Vitamin D 10 g 90 tablets (3 month supply) -ms-flex-pack: center; display: flex; TEST ONCE, unlike other tests, no need to retest a couple of days after the 1st test, unless new symptoms appear! 12 Months. -ms-flex-item-align: center; FlowFlex is a rapid test. Your session is about to timeout due to inactivity. color: #fff !important; /* Update text colour colour */ Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test. A common rapid at-home COVID test has become the subject of a recent product recall over concerns the antigen test hasn't received proper U.S. authorization. display: block; Picture 1 of 3. -webkit-box-align: center; For more information see our delivery help or view our returns policy. } Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) RM 11.90 RM 9.90 Product Specification Test time: 15 minutes Sensitivity: 97.1% Specificity: 99.5% Sample type: Nasal Swab Storage Condition: 2c to 30 c Catalog: L031-118M5 Request for Quote (Orders above 300 units) First Name Last Name Email Address Contact Number Company Name (If Any) For self-testing use. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication, report the problem through the MedWatch Voluntary Reporting Form, Report any problems you experience with the Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) to the FDA, including suspected false results. Before you begin the test, it is important to read and follow the detailed instructions in the package insert. March 11, 2022, Update: The FDA updated this safety communication to clarify that the ACON Flowflex SARS-CoV-2 Antigen Rapid Tests (Self-Testing) in dark blue packaging are a product of ACON Biotech (Hangzhou) Co., Ltd. The Flowflex COVID-19 Rapid Antigen Test enables you to effectively detect COVID-19, including the Omicron variant, with 98.8% accuracy in less than 15 minutes. The earliest delivery date for these orders will be shown at the checkout. } The FlowFlex COVID-19 Antigen Home Test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected direct anterior nasal swab samples from individuals aged two years or older. We're Open & Still Delivering Your Print! margin: 0 auto; Since the launch of its Flowflex COVID-19 Antigen Home Test, ACON Laboratories, Inc. has continued testing for product stability to extend the shelf-life. If your Flowflex test box looks like this, it's being recalled. Need Help? ACON Laboratories, Inc. has been continuously monitoring the emergence of SARS-CoV-2 variants to ensure that the Flowflex COVID-19 Antigen Home Test can detect them. This test kit is approved to be used in home. width: auto; If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you toreport the problem through the MedWatch Voluntary Reporting Form. The FDA is concerned about the risk of false results when using this unauthorized test. If you have specific healthcare concerns or questions about the products displayed, please contact your licensed healthcare professional for advice or answers. Registered VAT number 116300129. Named Day Delivery Should you need a verified test with a certificate, please visit https://www.boots.com/covid-19-testing/pre-departure-to-uk-covid-19-travel-testing, https://www.boots.com/covid-19-testing/pre-departure-to-uk-covid-19-travel-testing, Find out more about international delivery, Flowflex Antigen Rapid Test Lateral Flow Self-Testing Kit 5 Tests. Approved globally by 40+ countries; European Union, China, United Kingdom, Singapore, Australia, Canada and more. While the FlowFlex antigen test is a one-test-per-box package, it's sold at a lower $10 . } .cu-ticker { Conversely, the Flowflex SARS-CoV-2 Antigen Rapid Test (ACON Laboratories) showed a higher sensitivity for delta compared with other Ag-RDT kits ( appendix pp 1-2 ). Please try again or use a different postcode or place name. Menu . Subscribe to get special offers, free giveaways, and once-in-a-lifetime deals. Flowflex tests that look like this are authorized and available in the US. Flowflex COVID -19 Antigen Home Test SKU AC-L031-118B5 Special Price $3.99 Regular Price $5.99 (300 Tests) Printed expiration date on box is 02/2023; but FDA has granted a 9 month extension. *Other COVID-19 antigen home tests may require a 2nd test 2-3 days after the first. All rights reserved, The Food and Drug Administration issued a recall, Mysterious Cases of Men Found Dead After Leaving NYC Gay Bars Ruled Homicides: ME, Actor Tom Sizemore, of Saving Private Ryan,' Dies at 61, Viral Kids' Star Ms. Rachel Is Taking a Break From Social Media After Backlash Over Co-Star Who Uses They/Them Pronouns, This 26-Year-Old Pays $0 to Live in a Luxury Tiny Home' She Built for $35,000 in Her Backyard Take a Look Inside, NYC Winter Storm: 12 Hours of Rain, 40 MPH Winds and Snow Expected; See Timing Here, Columbia Dumps SAT Admissions Requirement for Good. VAT: 25.79. Product contents: 5 Test Cassettes 5 Extraction Buffer Tubes 5 Waste Bags 5 Nasal Swabs Product Insert in both Traditional Chinese and English This guide tells you how to: prepare the test take a swab sample from. Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test. %%EOF The Flowflex COVID-19 Antigen Home Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. This coronavirus (COVID-19) rapid nose-only test comes in a blue and white pack with the ACON Flowflex brand on it. Before you begin the test, it is important to read and follow the detailed instructions in the package insert. The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. The FlowFlex Rapid Test Kit is currently the most accurate and affordable test on the market. Hover to zoom. [{"id":42156042780917,"title":"Default Title","option1":"Default Title","option2":null,"option3":null,"sku":"","requires_shipping":true,"taxable":false,"featured_image":null,"available":true,"name":"FlowFlex SARS-CoV-2 COVID-19 Low Level Nasal Non-Invasive Swab Antigen Rapid Test Kits","public_title":null,"options":["Default Title"],"price":1999,"weight":136,"compare_at_price":null,"inventory_management":"shopify","barcode":"","requires_selling_plan":false,"selling_plan_allocations":[]}], Safe for children as young as 2 years old, Can be used to test children as young as 2 years old, For use with and without COVID-19 symptoms, No need to send it off to a lab to obtain results, Compact packaging for On-The-Go testing. text-align: left; font-size: .82rem !important; FlowflexCOVID-19 Antigen Rapid Home Test Kit The 15-minute, at-home, rapid coronavirus antigen testing kits from FLOWFLEX are a great option for those looking to get fast, accurate results. font: 1rem/1.3 "Boots Sharp",Arial,sans-serif !important; Future shelf-life expiration date extensions will be communicated as they become available. The FDA will continue to keep the public informed of significant new information. For use under an Emergency Use Authorization (EUA) only. color: inherit; .cu-ticker .cu-ticker--container .button:hover { v2"XD2kKS7a03jK7 E/rl:U8p_ {a For the most up-to-date news and information about the coronavirus pandemic, visit the. } The Flowflex COVID-19 Antigen Home Test is all you need to determine your familys Covid-19 status, whether symptoms are present or not. Copyright 2023 NBCUniversal Media, LLC. U.K. Government validated at Public Health England, Porton Down Laboratories. Standard Delivery .cu-ticker .cu-ticker--container .cu-ribbon--icon { 2021 ACON Laboratories, Inc. | All Rights Reserved. .cu-ticker .cu-ticker--container .button { Are you sure you want to remove this product? o Clinical performance showed 93% sensitivity and 100% specificity. In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and. A recall notice by ACON Laboratories identifies a rapid antigen test (left) in blue packaging that has been recalled, next to its U.S. approved product (right) packaged in a white box. Instore & online vce. Item No. Fast Accurate Easy to use Reliable CE marked Specimen: Anterior nasal swab specimens Test time: Results at 15 mins Shelf life: 24 months Storage temperature: 2-30oC Accuracy: 98.8% On occasion, manufacturers may improve or change their product formulas and update their labels. The site is secure. Recepty.cz Blesk pro eny Maminka.cz eny.cz Reflex.cz E15.cz FITweb.cz Auto.cz iv.cz. padding: 0; Disabled or chronically sick people can claim VAT relief on purchases for personal or domestic use that are applicable to their disability or sickness. In order to buy non-prescription medicines you must be a registered user of our site as we are obliged to record your transaction history. ACON Laboratories, Inc. has initiated a recall for all unauthorized ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Tests (Self-Testing) tests that were distributed in the U.S. The government of Orange County postponed the previously scheduled distribution of the recalled tests planned for Monroe, and announced that anyone who received the test at Wallkill and New Windsor events can exchange their antigen test for a new one at a later event. The U.S. Food and Drug Administration (FDA) is warning people not to use certain ACON COVID-19 tests, a product of ACON Biotech (Hangzhou) Co., Ltd. People should not use the ACON Biotech test named Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) that is packaged in a dark blue box (see images below). 3.95 - choose a weekday within the next 14 days for delivery. .cu-ticker .cu-ticker--container .button { Free Postage. "Attributes" : { If it's been more than two weeks since you've used one of the tests and you don't have any symptoms, it's not necessary to test again, per the FDA. Features: Detects active COVID-19 infection 2958813. Flowflex Antigen Rapid Lateral Flow 5 TESTS Covid 19 Home Testing UK Pharmacy. No app is needed to use the test. color: rgb(255, 255, 255); Negative test results do not exclude infection with COVID-19 and face masks, social distancing and good hygiene practice must be maintained. At-home tests and the omicron variant. - Nasal and Nasopharyngeal swab specimens - Results in 15 minutes - Excellent performance compared to molecular methods -webkit-transition: all 0.2s ease-in-out; If you have questions about this Safety Communication, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100. Use Find in store below to see if its in stock near you. The highest overall sensitivity for all SARS-CoV-2 used was shown by Flowflex, which detected Omicron with slightly higher sensitivity than Delta variant but lower than Alpha, Beta, Gamma, and. Flowflex COVID-19 Antigen . .cu-ticker .cu-ticker--container .cu-ribbon--text strong { Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test as shown in the Porton Down. Please select the correct area: Prices may vary depending on the store. The Flowflex and Healgen tests pick up moderate to high viral loads. Easy Covid-19 antigen home test step-by-step instructions ensure that the self-testing is taken . A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. color: #cc0033; BUY FLOWFLEX TEST KIT ONLINE More Tests Available Quick View Please log in to your account to add products to your favourites. font-size: .7rem !important; padding: 6px 9px 5px 9px !important; Free delivery for many products! The easy-to-use at-home test has been approved in European and other markets, but did not receive the required emergency use authorization by the FDA. >98%, 15-20 . HSA/FSA cards can be accepted in-store but not on Target.com. NO SYMPTOMS Needed - The Flowflex COVID-19 Home Test has been authorized to test patients with or without COVID-19 symptoms. .cu-ticker .cu-ticker--container .button { H/NzYjzjV]2"iy +>C$Iq$y;my}AdQbQgeF$}e\M,q8"B^c]#g2iE>La4,xW%[Otucj(S-DE*qLv {x 8Vv2o/70Mz({J+`] 4T "catentry_id" : "2676648", Detects Active COVID-19 Infection Antigens indicate active disease, find out if you have COVID-19 by performing a painless . -ms-grid-row-align: center; It does not differentiate between SARS-CoV and SARS-CoV-2. The tests being recalled come in a blue box and are manufactured by ACON Biotech (Hangzhou) Co., Ltd, which can be seen on the back of the box. Packaged in a white box and given the proper emergency use authorization, the "Flowflex COVID-19 Antigen Home Test" is approved in the U.S. Consumers in possession of the unauthorized test are encouraged by the FDA to dispose of the product and if already used to detect a possible COVID infection, seek an additional test from a federally approved provider. Get Back to Sharing Special Moments with Family and Friends. 7.45. The Flowflex COVID-19 Antigen Home Test has an expiration date that is extended by 9 months. -ms-flex-item-align: center; A rapid test for the detection of COVID-19 antigens in nasal specimens. "ItemImage" : "/wcsstore/eBootsStorefrontAssetStore/images/NoImageIcon.jpg", Headquartered in San Diego, California, ACON Laboratories makes point-of-care medical diagnostics accessible to people around the world. Blog. margin-left: 20px !important; Spice up your small talk with the latest tech news, products and reviews. #text-4156288950 > * { Sign up to receive email updates on medical device recalls, safety communications, and other safety information. For more information see our delivery help or view our returns policy. 267 0 obj <>/Filter/FlateDecode/ID[<37EBE39B4A765A85C7911C0DFB92A584><2F8B2D9AC0570041A82CDA2C5E51F00F>]/Index[43 251]/Info 42 0 R/Length 595/Prev 431472/Root 44 0 R/Size 294/Type/XRef/W[1 3 1]>>stream text-decoration: none; font-size: .74rem; Usually delivered between 8am and 9pm. } Delivered on weekdays. Very high sensitivity. This test cannot be used for travel. The FlowFlex COVID-19 Antigen Home Tests are suitable for medical professionals and the public to use. Small enough to be a stocking stuffer. A simple nasal swab makes it convenient and easy to use. h|]Hausd4/E]XAV7QL>bY}@Xf(Sdy:t`M]uE=Qwp ;!v:e,s*`k^9E 7QynsUiVfaxoo aqR&;l_ZDq.%L9k 9!f For general use. SMALL PACKAGING. *Please note the NHS portal does not accept results/QR code reports from consumer bought tests, it can only be used for free NHS supplied tests More Product Information 47 Reviews View all Flowflex A CE marked rapid lateral flow test 5 pack for the detection of Covid 19 Antigens in nasal swab specimens. )C|$)EYD(a%I8"BcD &8`EItnLN \'l_^wXuA9;zq^:P$KhzYpA } No Prescription Required - Authorized under FDA EUA, for home use. The Flowflex COVID-19 Antigen Home Test has an expiration date that is extended by 9 months. Boots.com is a trading name of Boots UK Limited. While the Flowflex test that comes in a white box with the full name "Flowflex COVID-19 Antigen Home Test" is safe to use (it has an emergency use authorization from the FDA), there's a risk of counterfeit tests being sold in the US with a blue box and a slightly different name, "Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing)," according to a company recall by the maker of the authorized Flowflex tests, ACON Laboratories. -ms-flex-item-align: center; Blue-boxed Flowflex COVID-19 tests are legally available in Europe under the same name because they're regulated there. Menu. The Flowflex COVID-19 Antigen Home Tes t is an easy-to-use, rapid nasal swab test that detects an active COVID-19 infection in 15 minutes. font-weight: 600; This test cannot be used for travel. Detect Omicron, Delta and other COVID-19 variants, with 98.8% accuracy in less than 15 minutes. RESULTS that let you enjoy family time, while worrying less about COVID-19. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Delivery options At least, if you got it in the US. hKAB-^TFE]+.EAaXbAhTFtQ3E4ZEI)J='p3s?+TkLRn))IeUe ve7xL9(>@9[#tcWbjEYO1 P)s:U_/3|Mk1F-s0+2wf;#: JCY {5i/&_wQxxDB*_r2VDn>)hx]uNwCkB%sRsxGj/oc&OXs R[Smz&ts,qNa+t?g08dV
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