FDAJanuary 14, 2019device

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 pathog...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

becton dickinsonbectonbecton dickinson

UPCs

00382904429638

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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