PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: June 14, 2023 Initiated: May 1, 2023 #Z-1682-2023

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Becton Dickinson & Co.
Units Affected
70,948 EA
Distribution
Worldwide distribution - US Nationwide and the countries of CA, CL, HK, TW.
Location
Sparks, MD

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Becton Dickinson & Co.. Units affected: 70,948 EA.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2023. Severity: Moderate. Recall number: Z-1682-2023.

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