# FDA recall Z-0954-2021

> **Becton Dickinson & Co.** · Class II · device recall initiated 2021-01-07.

## Product

BioGX SARS-CoV-2 Reagents for BD MAX System  Catalog number (REF) 444213.  In vitro diagnostic.      SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.

## Reason for recall

Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and use two of the same tubes, there is a low potential for a false negative SARS-CoV-2 result. A false negative SARS-CoV-2 result could lead to an increased risk of disease progression for the patient and additional spread of SARS-CoV-2 if the patient is not quarantined.

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-0954-2021
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-07
- **Report date:** 2021-02-17
- **Termination date:** 2021-12-03

- **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-0954-2021

## Citation

> AI Analytics. FDA recall Z-0954-2021. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/Z-0954-2021. Source: US FDA. Licensed CC0.

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