BD Veritor System for Rapid Detection of SARS-CoV-2 recall
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…
Why was BD Veritor System for Rapid Detection of SARS-CoV-2 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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: N/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
- Product
- 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…
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 70,948 EA
- Distribution
- Worldwide distribution - US Nationwide and the countries of CA, CL, HK, TW.
- Recall date
- June 14, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)