Reported Mar 13, 2019 · Terminated

BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX…

Becton Dickinson & Co.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Becton Dickinson & Co. · 7 Loveton Cir · Sparks, MD · 21152-9212

Is this the product you have?

  • BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use
  • with the BD MAX System Catalog Number442963 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
Lot codes and dates
  • Lot number/UDI 8194784 (01)00382904429638 (17)200222(10)8194784(30)1 and 8199682 (01)00382904429638 (17)200222(10)8199682(30)1
  • Expiration Date2020-02-22
Amount recalled
1583 assay kits

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 3, 2020 · Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.