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Becton Dickinson & Co. recalls BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, s
Recalled June 14, 2023 · FDA recall Z-1682-2023 · Becton Dickinson &
Hazard
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 · FDA Class II
Units
70,948 EA
Sold at
Worldwide distribution - US Nationwide and the countries of CA, CL, HK, TW.
Description
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
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 detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088
Manufacturer(s)
Becton Dickinson & Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →