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. ACON Laboratories Flowflex. The current lot in circulation, LOT: COV201007, with a printed expiration date of January 2023, has been extended to October 2023. ;)K@ endstream endobj startxref Do not use with multiple specimens. 3 8fcgp[v. Our top picks are based on our editors independent research, analysis, and hands-on testing. $10 from Walgreens May be out of stock $5 from WellBefore $8 from Target Abbott BinaxNow COVID-19 Antigen Self. |kwj/3#;MjYV4w ]@w6`%fyjMea*P(=G)b=Li2FOkoIpo~6DR$]? r $yQ'U9g6O~; g29|>BoF=/-wz nrZ=.``u0DmD Generally, the expiration dates are stamped on the back of the package. This is not a complete list, and many other brands of tests have had their expiration dates extended. Refer to the table for the new expiration date using the lot number printed on the test kit box. Do Home Covid Tests Expire? - The New York Times Then click on the link in the right-hand column to find the new expiration date for your batch. 83 0 obj <>stream Xtrava Health SPpera. The FDA may have extended the expiration date of your at-home COVID-19 test. 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. 4. Terms & Conditions Features: Updated Expiration Date Information Below Note: Includes Five Tests, Only One Test Needed Per Person Results in as Quick as 15 Minutes Can You Still Use an Expired COVID-19 Test? - Cleveland Clinic Refer to the table for the new expiration date using the lot number printed on the test kit box. If you have questions, please contact customer support at 1 (800) 838 9502. The site is secure. MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX COVID 19 ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. Check iHealth tests. and the box says it has expired, some epidemiologists say that it can still be used under certain conditions. Check the box for the "Expiration" or "Use By" date. Abbott BinaxNOW Self-Test; iHealth COVID-19 Rapid Antigen Test; On/Go At-Home COVID-19 Rapid Antigen Test 1665 0 obj <> endobj 0 That means you might have a test at home that's passed its expiration date, but if you call the company or dig through the F.D.A. as long as each tests control line the line that is typically next to the letter C is easily visible when the test is complete. The Flowflex 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 swab specimens. Sign up to receive email updates on medical device recalls, safety communications, and other safety information. We are pleased to announce that the request to extend theFlowflexCOVID-19 Antigen Home Test shelf-life from 12 months to 24 months, when stored at 36-86F (2-30C),has been granted. ACON Laboratories Issues a Recall of Non-EUA Authorized "Flowflex SARS The links below include lot numbers and expiration dates for the 15 brands of at-home COVID-19 tests that have had their shelf lives extended by the FDA. Pilot COVID-19 At-Home. The Flowflex COVID-19 Antigen Home Test has an expiration date that is extended by 9 months. If you have an ACON Flowflex COVID-19 test, compare the packaging to the image above. Have an expired COVID test? You might still be able to use it - silive 2. Check carefully. At-Home COVID-19 Antigen Test Kits: Where to Buy and What You Should x[o6SqT*iQNvA!L'f?~M='zHy9?jez\_n~X}V8ps{]bm6W_Vo+cud:!zAZweVXo7m8>\,IN_V*+}*Qt~B@._GbykB##>kN@p=~3t^?nyKh#75a/sZk(?tg cWr0AwUU'0=_~;V[u'kkg_VQ(+9n JvIED}dZh|A++ylz3e.wO152=F:4Ncdc=;F>;Lz;D8,0y?]=!1SS>@,>q~qcn*N/BMN}}AAbo^=xhB=t1=tN2]fZK extensions for batches of expired laboratory tests, or have endorsed their own extensions for at-home tests authorized by federal regulators. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. COVID-19 Antigen Home Test - Instructions for Use for Healthcare Providers People with symptoms that began within the last 7 days. For more on COVID-19 testing, here's how to pay for home COVID tests with your FSA or HSA. Before sharing sensitive information, make sure you're on a federal government site. Do not use the test if the pouch is damaged or open . Some health departments have posted notifications on their websites when a manufacturer is granted an extension for its tests. When she's not writing, she enjoys playing in golf scrambles, practicing yoga and spending time on the lake. Flowflex Covid-19 Antigen Home Test (ACON Laboratories Inc.): Extended to 16 months from 12 months BD Veritor At-Home Covid-19 Test (Becton, Dickinson and Company): 6 months The FDA has extended the shelf life for some COVID-19 tests. Here's why: The COVID-19 test parts could degrade or break down over time, leading to inaccurate or invalid test results.See below to find out if your box of COVID-19 tests are still OK to use, as it's possible the expiration date has been extended. Can't find your test? Phone: 1-858-875-8000 Fax: 1-858-200-0729 Email: info@www.aconlabs.com. There've been no reports of adverse events, but because the duplicate tests . Future shelf-life expiration date extensions will be communicated as they become available. Future shelf-life expiration date extensions will be communicated as they become available. The FDA has compiled a list of 23 different at-home COVID tests along with their most accurate and up-to-date expiration dates. 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. The unauthorized ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing) uses a nasal swab sample to detect proteins, called antigens, from SARS-CoV-2, the virus that causes COVID-19. float:right; When Do Many At-Home Coronavirus Test Kits Expire? - The New York Times The F.D.A. Check the expiry date before you do the test. Unless the FDA has extended the shelf life of your box of COVID-19 tests, it's not recommended you use them after they've expired. Sarah Tew/CNET In March, Californias Public Health Department approved the emergency use of at-home test kits beyond their F.D.A.-authorized expiration dates. Diagnostic tests can show if you have an active COVID-19 infection. People with symptoms that began within the last 4 days. It's one of eight authorized antigen tests, which detect the presence of the SARS-CoV-2 nucleocapsid protein. Coronavirus (COVID-19) and Medical Devices, Recalls, Market Withdrawals and Safety Alerts, Coronavirus (COVID-19) and Medical Devices, Counterfeit At-Home OTC COVID-19 Diagnostic Tests, At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions, Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers, Face Masks, Barrier Face Coverings, Surgical Masks, and Respirators for COVID-19, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA), Contacts for Medical Devices Related to COVID-19, General Information About At-Home OTC COVID-19 Diagnostic Tests, List of Authorized At-Home OTC COVID-19 Diagnostic Tests, In Vitro Diagnostics EUAs: Tables of IVD EUAs, See link for list of updated expiration dates, Cue COVID-19 Test for Home and Over The Counter (OTC) Use, MaximBio ClearDetect COVID-19 Antigen Home Test, link for list of updated expiration dates, INDICAID COVID-19 Rapid Antigen At-Home Test, CLINITEST Rapid COVID-19 Antigen Self-Test, Speedy Swab Rapid COVID-19 Antigen Self-Test, Azure FaStep COVID-19 Antigen Pen Home Test, Lucira by PfizerCOVID-19 & Flu Home Test, Status COVID-19 Antigen Rapid Test for Home Use, Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results, At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication, COVID-19 Testing: What You Need to Know | CDC, COVID-19 Self-Testing At-Home or Anywhere | CDC, What to Do If You Were Exposed to COVID-19 | CDC, Isolation and Precautions for People with COVID-19 | CDC. Flowflex at Home Covid Test Kit, 5 Test Pack Item 1618171 Write a review Shipping & Handling Included* $10 OFF $10 savings is valid 6/12/23 through 7/2/23. expiration date COV1100041 - COV1100088 October 2022 October 2023 . Show submenu for Vaccines, Testing, Instructions, Show submenu for Hygiene, Safety & Campus Operations. The FDA is working with ACON Laboratories, Inc. to resolve this safety issue. The .gov means its official.Federal government websites often end in .gov or .mil. This means you collect your own sample, perform the test, and read the result yourself without the need to send a sample to a laboratory. San Diego, CA, November 2, 2020 ACON Laboratories, Inc., a leading global medical device manufacturer announced today the launch of its Flowflex SARS-COV-2 Antigen Rapid Test. Visit the FDA website, scroll down to the table and find your test. The at-home test manufactured by Acon Laboratories and labeled "Flowflex COVID-19 Antigen Home Test" were extended by the FDA as well. 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). If the date has already passed, continue these steps to see if the expiration date has been extended by the FDA. The test is stable until the expiration date printed on the sealed pouch. Refer to the table for the new expiration date using the lot number printed on the test kit box. Flowflex COVID-19 Home Test, 1 Test - amazon.com Result window 1ACON Biotech (Hangzhou) Co., Ltd.Specimen well No.210 Zhenzhong Road, West Lake DistrictHangzhou, P.R.China, 310030 Wash or sanitize your hands. The test is to be performed two times over three days (serial testing). Be sure both the manufacturer and test name are correct . @4;d8@lbDS@jbL@g0?Plz ` g There are two types of COVID-19 diagnostic tests, molecular and antigen, which detect different parts of the virus. The FDA will update this table as additional shelf-life extensions are authorized. People with symptoms that began within the last 6 days. VDH: COVID cases and deaths decline | Vermont Business Magazine Also make sure to check the expiration date, even if it is on the list. Covid Test Expired? You May Still Have Time to Use It You'll need it for the next step. An official website of the State of North Carolina, Check the Expiration Date for Your At-Home COVID-19 Test, Healthier Together - Health Equity Action Network. In some cases, the expiration date for a test may be extended. The company made the announcement about the other Flowflex tests in January, and the FDA published it on Friday. New over-the-counter COVID-19 test authorized by the FDA FDA Home; Medical Devices; Databases - 510(k) | . ACON's test [] Flowflex SARS-CoV-2 Antigen Rapid Test - ACON Bio In the table below, the "Expiration Date" column lists the shelf-life and where to find the expiration date for that test. An extended expiration date means the manufacturer provided data showing that the shelf-life is longer than was known when the test was first authorized. Abbott Diagnostics Scarborough, Inc.:BinaxNOW COVID-19 Ag Card Home Test, Abbott Diagnostics Scarborough, Inc.:BinaxNOW COVID-19 Antigen Self Test, Access Bio, Inc.:CareStart COVID-19 Antigen Home Test, ACON Laboratories, Inc:Flowflex COVID-19 Antigen Home Test, Aptitude Medical Systems Inc.:Metrix COVID-19 Test, Celltrion USA, Inc.:Celltrion DiaTrust COVID-19 Ag Home Test, CTK Biotech, Inc.:ImmuView COVID-19 Antigen Home Test, Cue Health Inc.:Cue COVID-19 Test for Home and Over The Counter (OTC) Use, Genabio Diagnostics Inc.:Genabio COVID-19 Rapid Self-Test Kit, iHealth Labs, Inc.:iHealth COVID-19 Antigen Rapid Test, InBios International Inc:SCoV-2 Ag Detect Rapid Self-Test, Lucira Health, Inc:Lucira CHECK-IT COVID-19 Test Kit, Maxim Biomedical, Inc.:MaximBio ClearDetect COVID-19 Antigen Home Test, Mologic, Inc.:COVI-Go SARS-CoV-2 Ag Self-Test, OraSure Technologies, Inc.:InteliSwab COVID-19 Rapid Test, PHASE Scientific International, Ltd.:INDICAID COVID-19 Rapid Antigen At-Home Test, Quidel Corporation:QuickVue At-Home OTC COVID-19 Test, SD Biosensor, Inc.:Pilot COVID-19 At-Home Test 1, FDA Safety Communication - Recall of Certain Lots, Siemens Healthineers:CLINITEST Rapid COVID-19 Antigen Self-Test, Watmind USA:Speedy Swab Rapid COVID-19 Antigen Self-Test, Xiamen Boson Biotech Co., Ltd.:Rapid SARS-CoV-2 Antigen Test Card, SEKISUI Diagnostics, LLC. Calendar; Education / Schools; Forms; Local Links; Community News; Towns / Villages This coronavirus (COVID-19) rapid nose-only test comes in a blue and white . Want CNET to notify you of price drops and the latest stories? Terms and ConditionsTerms of Use Privacy Policy, 2022 ACON Laboratories, Inc. 10125 Mesa Rim Road, San Diego CA 92121. Yes, I also want to receive the CNET Insider newsletter, keeping me up to date with all things CNET. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19, and that the known and potential benefits. The table includes links to home use instructions for each test. $7.97 Get Fast, Free Shipping with Amazon Prime FREE delivery Friday, June 30 on orders shipped by Amazon over $25 Or fastest delivery Thursday, June 29. Find the original expiration date on the box label of your test and then look for the new expiration date in the "updated expiration dates" table for your test. If the Expiration Date column says that the shelf-life is "extended," there is a link to "updated expiration dates" where you can find a list of the original expiration dates and the new expiration dates. Make sure . On that page, the FDA page lists COVID-19 tests alphabetically, or you can use a search box to find your test directly. If a test kit has not received an authorized extension from the F.D.A. [CDATA[/* >