# FDA recall Z-1682-2023

> **Becton Dickinson & Co.** · Class II · device recall initiated 2023-05-01.

## 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

## 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

## Distribution

Worldwide distribution - US Nationwide and the countries of CA, CL, HK, TW.

## Key facts

- **Recall number:** Z-1682-2023
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-01
- **Report date:** 2023-06-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sparks, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1682-2023

## Citation

> AI Analytics. FDA recall Z-1682-2023. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-1682-2023. Source: US FDA. Licensed CC0.

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