# FDA recall Z-0981-2019

> **Becton Dickinson & Co.** · Class II · device recall initiated 2019-01-14.

## Product

BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System  Catalog Number: 442963    The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens.

## Reason for recall

False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets of the BD MAX Extended Enteric Bacterial Panel assay.

## Distribution

Worldwide Distribution: US (nationwide) to states of:CA, GA, HI, ID, MI, MN, MT, NJ, NM, OH, OR, PA, SC, TX, VA, VT, WA ; and to countries of: Australia, New Zealand, Canada, Europe, and Korea.

## Key facts

- **Recall number:** Z-0981-2019
- **Recalling firm:** Becton Dickinson & Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-14
- **Report date:** 2019-03-13
- **Termination date:** 2020-04-03

- **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-0981-2019

## Citation

> AI Analytics. FDA recall Z-0981-2019. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0981-2019. Source: US FDA. Licensed CC0.

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