# FDA recall Z-1416-2021

> **Becton Dickinson & Co.** · Class II · device recall initiated 2021-03-24.

## Product

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD  PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens  Catalog Number: 444213

## Reason for recall

BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration buffer tubes were not adequately sealed causing some tubes to be partially filled or empty upon use. A partially filled or empty rehydration buffer tube may lead to an Unresolved (UNR) result on the BD MAX" System

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-1416-2021
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-24
- **Report date:** 2021-04-21
- **Termination date:** 2022-08-02

- **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-1416-2021

## Citation

> AI Analytics. FDA recall Z-1416-2021. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-1416-2021. Source: US FDA. Licensed CC0.

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