The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1682-2023·Announced 2023-06-14

BD Veritor System Instructions for Use Not FDA Approved

The Instructions for Use for BD Veritor System rapid diagnostic tests for COVID-19 and flu were not FDA-approved, lacking proper specimen type specifications. Using the test with invalid specimen types could produce false positive or negative results, potentially delaying diagnosis or treatment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device with a functional deficiency that creates risk of false diagnostic results without reported illness or injury to date. The hazard involves a diagnostic test for serious respiratory infections where false results could delay diagnosis or treatment, meeting the rubric criterion for high-risk products where injury has not yet been reported.

Plain-English summary

BD Veritor System for Rapid Detection of SARS-CoV-2 and Influenza A and B is a rapid diagnostic test intended for simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B. Approximately 70,948 test units have been recalled. Distribution includes the United States, Canada, Chile, Hong Kong, and Taiwan.

The Instructions for Use (IFU) packaged with the test kits and available on the BD website were not FDA-approved and did not properly specify valid specimen types. This omission could lead users to perform testing with invalid specimen types, potentially producing false positive or false negative results.

False positive or negative results from this test could delay proper diagnosis or treatment for COVID-19 and influenza. Users with affected test kits should stop using them and contact the manufacturer or FDA for guidance on replacement or proper device disposal. Healthcare providers should verify test results through additional clinical assessment or alternative diagnostic methods if this device was used.

The recalled product

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
Becton Dickinson & Co.
Category
Medical Device — Rapid Diagnostic Test
Hazard
Affected units
70,948

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Becton Dickinson & Co.

See all →

Same hazard · mis labeling

See all →

Similar recalls