text-align: left !important; Do Not Use Certain ACON Flowflex COVID-19 Tests 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. 2958813. If you have an at-home COVID-19 Flowflex test that came in a dark blue box, don't use it, the US Food and Drug Administration said this month. } This test procedure overview does not replace the package insert. FlowFlex Covid-19 Antigen Rapid Test ART. For Self Test and Pro Use. "ItemImage" : "/wcsstore/eBootsStorefrontAssetStore/images/NoImageIcon.jpg", .cu-ticker .cu-ticker--container .cu-ribbon--text { Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) (pdf,975kb) (Rapid antigen test) Nasal swab. 8 January 2022. Flowflex Rapid Covid-19 Antigen Home Test are an at-home nose swab test that detects the presence of COVID-19. Never be without your favourite Boots products with our international delivery options. In this window lateral flow tests, such as Flowflex and Healgen are very effective. } Flowflex L031-118B5, COVID Rapid Antigen Home Test Kit, Each .cu-ticker .cu-ticker--container .cu-ribbon--icon { The SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of the onset of symptoms. Flowflex COVID-19 Antigen Home Test New Shelf-life Extension } NO SYMPTOMS Needed - The Flowflex COVID-19 Home Test has been authorized to test patients with or without COVID-19 symptoms. Flowflex L031-118B5 - COVID Rapid Antigen Home Test Kit, Each If your Flowflex test box looks like this, it's being recalled. 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. @media all and (max-width: 320px) { 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 the most up-to-date news and information about the coronavirus pandemic, visit the. #text-4156288950 { } 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. height: 1.5rem; The FlowFlex Rapid Lateral Flow Antigen Test Kit uses the latest patented technology to detect proteins, ensuring that it can detect new strains of the COVID-19 virus. 3.95 - choose a weekday within the next 14 days for delivery. Need something more bespoke? The Flowflex COVID-19 Antigen Home Test has an expiration date that is extended by 9 months. For self-testing. 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. 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. Find peace of mind with Flowflex! Have one to sell? 5x Flowflex Rapid Antigen Lateral Flow Covid Tests | eBay padding: 6px 9px 5px 9px !important; When you use the test, you can see if you carry COVID-19 antigens. } Free delivery for many products! Basket. Flowflex COVID-19 Antigen Home Test New Shelf-life - ACON LABS INC. How Accurate are FlowFlex Tests? Please Be Aware Postal Delays Are Possible Dismiss, Buy Covid 19 Test Kits Online Direct From UK Distributor, FlowFlex COVID-19 Rapid Test Kits (Single Pack), FlowFlex COVID-19 Rapid Test Kits (Multi Pack x 5), FlowFlex COVID-19 Rapid Test Kits (Multi Pack x 25). We recommend that you do not rely solely on the information presented on our Web or Mobile sites and that you review the product's label or contact the manufacturer directly if you have specific product concerns or questions. box-sizing: border-box; - Nasal and Nasopharyngeal swab specimens - Results in 15 minutes - Excellent performance compared to molecular methods Future shelf-life expiration date extensions will be communicated as they become available. Target does not represent or warrant that the nutrition, ingredient, allergen and other product information on our Web or Mobile sites are accurate or complete, since this information comes from the product manufacturers. Class 2 Device Recall FLOWFLEX SARSCOV2 Antigen Rapid Test Flowflex COVID-19 Antigen Home Test - Flowflexcovid.com } Flowflex Antigen Sars-Cov-2 Rapid Covid-19 Test. The FDA regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. The Food and Drug Administration issued a recall late last month for FlowflexSARS-CoV-2 Antigen Rapid Test (Self-Testing)," a product sold at an unknown number of pharmacies and distributed by local health officials. Straightforward and easy to read. margin: 0; -webkit-box-pack: center; Flowflex Lateral Flow Test SARS-CoV-2 Antigen pack of 5 Blue-boxed Flowflex COVID-19 tests are legally available in Europe under the same name because they're regulated there. Flowflex COVID-19 ART Antigen Rapid Test Kit (1 test/box) The FlowFlex Rapid Test Kit is uniquely packaged with its own individual serial number for mass testing and tracing . Just how accurate are rapid antigen tests? Two testing experts explain For in vitro diagnostic use only. The site is secure. HSA/FSA Eligible Restrictions apply; contact your insurance provider about plan allowances and requirements. The Flow flex COVID-19 Antigen Home Test is all you need to determine your family's COVID-19 status. align-self: center; Click OK to extend your time for an additional 20 minutes. 3M Aura 9320+ FFP2 Respirator Face Mask. The .gov means its official.Federal government websites often end in .gov or .mil. Get Back to Sharing Special Moments with Family and Friends. Information on how to contact ACON and the FDA can be found at the bottom of the recall announcement. Get the convenience of Flowflex! Panodyne SARS-CoV-2 Antigen Rapid Covid-19 Test 15 Minutes 24.50 4.49 Select options Flowflex and Panodyne COVID Rapid Test Kit (nasopharyngeal swab/oropharyngeal swab) with CE certification and intended for Health Professional Use to assist in the identification of the presence of the COVID-19 (Coronavirus) virus in the bloodstream. ACCURATE. Product details A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. Easy-to-use nasal swab test Can be used to test children as young as 2 years old For use with and without COVID-19 symptoms Results in 15 minutes No need to send off to a lab to obtain results Please log in to your account to add products to your favourites. } On occasion, manufacturers may improve or change their product formulas and update their labels. align-items: center; Before you begin the test, it is important to read and follow the detailed instructions in the package insert. The FlowFlex Rapid Lateral Flow Antigen Test Kit uses the latest patented technology to detect proteins, ensuring that it can detect new strains of the COVID-19 virus. Risks of. Best Home COVID-19 Tests - CNET The unauthorized test has a dark blue box with white lettering and symbols in the lower right corner of the box, including the letters CE and the name ACON Biotech (Hangzhou) Co., Ltd. identified on the outer box label. Flowflex COVID -19 Antigen Home Test - Rite Aid Easily fits in a purse or a small bag. FlowFlex COVID-19 Rapid Test Kits (Single Pack) - Flow Flex Rapid Test FDA Warns Against Some COVID Tests From Popular Brand Flowflex Spice up your small talk with the latest tech news, products and reviews. justify-content: center; STATEMENT ON THE NEW OMICRON VARIANTS (BQ.1.1, BQ.1, XBB.1.5, XBB, and BF.7), Flowflex COVID-19 Antigen Home Test New Shelf-life Extension, PUBLIC NOTICE OF COUNTERFEIT FLOWFLEX COVID-19 TEST KITS, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, Can be used to test children as young as 2 years old, For use with and without COVID-19 symptoms, No need to send off to a lab to obtain results, Compact packaging for On-The-Go testing. .cu-ticker .cu-ticker--container .cu-ribbon--icon ~ .cu-ribbon--text { The Flowflex COVID-19 Antigen Home Test is all you need to determine your familys Covid-19 status, whether symptoms are present or not. In this study, the accuracy of 11 Ag-RDTs to detect . Here's a quick overview of how it works: Sell it yourself. font-size: .74rem; TEST CHILDREN AGES 2 and up, who are too young for vaccinations. color: #cc0033; VAT: 25.79. The FlowFlex COVID-19 Antigen Home Tests are suitable for medical professionals and the public to use. Your session is about to timeout due to inactivity. "ItemThumbnailImage" : "/wcsstore/eBootsStorefrontAssetStore/images/NoImageIcon.jpg" 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.