Reported Jun 14, 2023 · Ongoing
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro,…
Becton Dickinson & Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton Dickinson & Co. · 7 Loveton Cir · Sparks, MD · 21152-9212
Is this the product you have?
- BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen
- and influenza A and/or B Catalog Number256088
- Lot codes and dates
- UDI-DIN/A Lot Number Expiration Date 2077698 01-06-23; 2077708 05-06-23; 2209447 05-11-23; 2209462 09-11-23; 2212158 09-11-23; 2241596 09-11-23; 2242261 12-11-23; 2259433 15-11-23; 2259612 12-11-23; 2283876 10-01-24; 2332350 01-02-24; 2332352 07-03-24; 2340087 15-03-24; 2340090 16-03-24; 2348229 17-03-24; 2348238 22-03-24; 2348241 22-03-24; 2364051 10-04-24; 3003941 12-04-24; 3004372 14-04-24; 3009033 16-04-24; 3009036 16-04-24; 3009093 16-04-24; 3009985 16-04-24
- Amount recalled
- 70,948 EA
Where it was sold
- Nationwide
- CA
Why it was recalled
IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,specifically describing specimen type, could cause use of the test with invalid specimen types, which may produce false positive or false negative results.Erroneous results can cause a delay in diagnosis or treatment
This product could cause temporary or reversible health problems — stop using it.
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