Are you sure you want to remove this product? Easily fits in a purse or a small bag. No app is needed to use the test. Flowflex COVID-19 Home Test, FDA authorized Antigen test that requires only 1 test, results in 15 minutes, Nasal Swab. text-align: left; border: 1px solid #fff; Flowflex Rapid Covid-19 Antigen Home Test - Vitality Medical 5x Flowflex Rapid Antigen Lateral Flow Covid Tests | eBay Straightforward and easy to read. This coronavirus (COVID-19) rapid nose-only test comes in a blue and white pack with the ACON Flowflex brand on it. Future shelf-life expiration date extensions will be communicated as they become available. The Flow flex COVID-19 Antigen Home Test is all you need to determine your family's Covid-19 status, whether symptoms are present or not. 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. 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. Flowflex Rapid Covid-19 Antigen Home Test are an at-home nose swab test that detects the presence of COVID-19. As of November 18, 2022, the expiration date of the Flowflex COVID-19 Antigen Home Test has been extended by 9 months. Flowflex L031-118B5, COVID Rapid Antigen Home Test Kit, Each Flowflex Antigen Sars-Cov-2 Rapid Covid-19 Test. The manufacturer of the Flowflex tests, ACON Laboratories, said it was aware of the "unauthorized, adulterated and misbranded counterfeit product" and issued a recall order on Jan. 9. Just how accurate are rapid antigen tests? Two testing experts explain Class 2 Device Recall FLOWFLEX SARSCOV2 Antigen Rapid Test FlowflexCovid-19 Antigen Home Test Consumer Package Insert. 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. -ms-flex-item-align: center; Picture Information. [ My Account. :G4IFw74It\hth}. Flowflex SARS-CoV-2 Antigen Rapid Single Test Kit FFCT1. All rights reserved. font-size: .7rem !important; text-align: left; Flowflex COVID-19 Antigen Home Test Package Insert If you have specific healthcare concerns or questions about the products displayed, please contact your licensed healthcare professional for advice or answers. Flowflex SARS-CoV-2 Antigen Rapid Test with Video Observation Services for Travel. 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. DETECTS ACTIVE COVID-19 INFECTION Antigens indicate active disease, find out if you have COVID-19 by performing a painless nasal swab. Flowflex COVID-19 ART Antigen Rapid Test Kit (1 test/box) ACON provides rapid diagnostics and healthcare products based on a philosophy of high quality at affordable prices. Headquartered in San Diego, California, ACON Laboratories makes point-of-care medical diagnostics accessible to people around the world. 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) #text-4156288950 { .cu-ticker .cu-ticker--container .cu-ribbon--text { 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. 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 $35,000 in Her Backyard Take a Look Inside, NYC Winter Storm: 12 Hours of Rain, 40 MPH Winds and Snow Expected; See Timing Here, Columbia Dumps SAT Admissions Requirement for Good. For general use. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. endstream endobj startxref color: #cc0033; align-self: center; Product Description. The Flow flex COVID-19 Antigen Home Test is all you need to determine your family's COVID-19 status. Click to enlarge. The test is available in 1-Pack, 2-Pack and 5-Pack. Before you begin the test, it is important to read and follow the detailed instructions in the package insert. .cu-ticker { display: flex; )C|$)EYD(a%I8"BcD &8`EItnLN \'l_^wXuA9;zq^:P$KhzYpA display: block; h|]Hausd4/E]XAV7QL>bY}@Xf(Sdy:t`M]uE=Qwp ;!v:e,s*`k^9E 7QynsUiVfaxoo aqR&;l_ZDq.%L9k 9!f Flowflex Covid-19 Antigen Rapid Test 5pcs | Self Test | Medical Device #text-15297007 > * { text-align: center; The Flowflex COVID-19 Antigen Home Test is all you need to determine your familys COVID-19 status. The FDA will continue to keep the public informed of significant new information. background: #fff; Product details A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. On occasion, manufacturers may improve or change their product formulas and update their labels. Back in January 2022, the FDA recalled a counterfeit version called Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) that hasn't been authorized for sale in the US. Shop COVID-19 Antigen Rapid Home Test Kit and read reviews at Walgreens. .cu-ticker .cu-ticker--container .button { The FlowflexCOVID-19 Antigen Rapid Home Test Kit isa great option for those looking for quick results. Your session is about to timeout due to inactivity. Additionally, the FlowFlex Lateral Flow Test Kits has been certified for detecting the Omicron COVID Variant . Please use this overlay to check for product availability. All components, and step-by-step instructions, needed to test are included. Flowflex Lateral Flow Test SARS-CoV-2 Antigen Rapid - Box of 25 [COVID Test - Acon] 21.49. Testing for antigens is another way to determine if you contracted COVID-19, especially if you are asymptomatic. Flowflex SARS-CoV-2 Antigen Rapid Test - ACON Bio .cu-ticker .cu-ticker--container { } 11 Rapid At-Home Covid-19 Testsand Where to Find Them | WIRED As of this week, the manufacturer said it has not received any reports of "adverse events" related to either test and has issued the recall "out of an abundance of caution.". Before sharing sensitive information, make sure you're on a federal government site. margin-left: 50px; { Affordable Easy-to-Use Nasal Swab Test Results in 15 minutes Safe for children as young as 2 years old Flowflex COVID-19 Antigen Home Test New Shelf-life - ACON LABS INC. Flowflex COVID -19 Antigen Home Test - Rite Aid }, We are here to help if you have a question. Blue-boxed Flowflex COVID-19 tests are legally available in Europe under the same name because they're regulated there. It is intended for self-testing use. Do not use the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) in the dark blue packaging, as shown above. For self-testing use. FlowFlex ANTIGEN Rapid Individual Test Kit Hover to zoom. The FDA is concerned about the risk of false results when using this unauthorized test. 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. There've been no reports of adverse events, but because the duplicate tests haven't been tested or authorized by the FDA, there's a possibility of a false negative or false positive result. } align-self: center; } display: flex; } The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. Flowflex COVID -19 Antigen Home Test - CLIAwaived Inc. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization, Safe for children as young as 2 years old. PDF Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) The ACON Laboratories Flowflex COVID-19 Antigen Home Test, authorized by the FDA on October 4, 2021, is not the subject of this Safety Communication and can continue to be used. Before CNET, she worked in local journalism covering public health issues, business and music. 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. 3.75 or free when you spend 25 or more. This test kit is approved to be used in home. display: -ms-flexbox; Refer to the table for the new expiration date using the lot number printed on the test kit box. Flowflex Rapid Tests - Covid-19 Lateral Flow Results in 15 Minutes #text-4156288950 > * { TEST ONCE, unlike other tests, no need to retest a couple of days after the 1st test, unless new symptoms appear! Can be used on children as young as 2 years old. DivgX$nGJ3LU-{49MNPQT^UPX#\\?yQ~ margin-left: 20px !important; This product now has effective expiration date of November 2023. 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. margin: 15px auto; -ms-grid-row-align: center; padding: 8px 19px 7px 19px; 3M Aura 9320+ FFP2 Respirator Face Mask. 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 ). } For self-testing. justify-content: center; A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens. 8.99. margin: 0 auto; } FlowFlex Covid-19 Antigen Rapid Test ART. For Self Test and Pro Use. Negative test results do not exclude infection with COVID-19 and face masks, social distancing and good hygiene practice must be maintained. Information on how to contact ACON and the FDA can be found at the bottom of the recall announcement. TEST CHILDREN AGES 2 and up, who are too young for vaccinations. Instore & online All orders fully Tracked } 2958813. 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 The Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens. Find peace of mind with Flowflex! 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. } "Attributes" : { Delivery options Please click here to check the new expiration date using the lot number printed on the test kit box. How does this test work? Flowflex Antigen Rapid Test Kit Single - eprint.co.uk At-Home COVID-19 Antigen Test Kits: Where to Buy and What You Should 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. 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. Critical Information When & Where You Need It. Flowflex - AusDiagnostics The recall caught the attention of public health officials in at least one New York county, who issued a notice to residents on Friday. 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. "COVID-19 Antigen tests in the U.S. market that lack FDA approval, clearance, or authorization can pose significant risk since they may lead to inaccurate test results, including false negative or false positive test results," a statement from the manufacturer said this week. 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. Copyright 2023 NBCUniversal Media, LLC. .cu-ticker .cu-ticker--container .button { 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. ACCURATE. Flowflex COVID-19 Antigen Home Test | Flowflex COVID Test Using a simple nasal swab within 2cm of the nose makes it extremely easy to administer an accurate test. iHealth COVID-19 Antigen Rapid Test, 2 Tests per Pack,FDA EUA Authorized OTC At-home Self Test, Results in 15 Minutes with Non-invasive Nasal Swab, Easy to . Operating instructions for FlowFlex SARS-CoV-2 Antigen Rapid Test with prefilled extraction buffer tubes. %PDF-1.6 % Flowflex Antigen Sars-Cov-2 Rapid Covid-19 Test - Tesco Groceries min-width: 80px; 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. *Other COVID-19 antigen home tests may require a 2nd test 2-3 days after the first. color: inherit; 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 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. Copyright The Boots Company PLC. This FlowFlex antigen test pack involves the most recent innovation in distinguishing proteins guaranteeing it recognizes new traces of the Coronavirus. COVID-19 rapid lateral flow test kit instructions: ACON Flowflex Registered office: Nottingham NG2 3AA.Registered in England: company number 928555. 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. The Flowflex COVID-19 Antigen Home Test has an expiration date that is extended by 9 months. The Flowflex COVID-19 Antigen Home Test is all you need to determine your familys Covid-19 status, whether symptoms are present or not. 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. Flowflex Antigen Rapid Lateral Flow 5 TESTS Covid 19 Home Testing UK Pharmacy. - Nasal and Nasopharyngeal swab specimens - Results in 15 minutes - Excellent performance compared to molecular methods Read more:How to Make Sure Your COVID Test Isn't Fake. This may not be available during public holidays or weekends in between public holidays. Can be used on children as young as 2 years old. For self-testing. A rapid test for the detection of COVID-19 antigens in nasal specimens. Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) -webkit-box-pack: center; This test procedure overview does not replace the package insert. 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. justify-content: center; Blesk.cz AHA! -ms-flex-item-align: center; color: #fff !important; /* Update text colour colour */ For use under an Emergency Use Authorization (EUA) only. Please choose a colour or size before adding this product to your favourites.