BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the… — Class II medical device recall Z-0981-2019
Terminated recall by Becton Dickinson & Co., reported 2019-03-13, distributed nationwide. False negative results with the BD MAX Extended Enteric Bacterial Panel when testing specifically for Enteroto
| Recall number | Z-0981-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2019-01-14 |
| Classified | 2019-03-06 |
| Reported by FDA | 2019-03-13 |
| Terminated | 2020-04-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, KR, NZ |
| Quantity | 1,583 assay |
| Reason classes | microbial contamination, potency |
| UPC / GTIN / UDI-DI | 00382904429638 |
| Model numbers | 442963 |
| Expiration dates | 2020-02-22 |
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.