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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