Becton Dickinson & Co.: 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 a

Is my product affected?

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

• UPC 00382904429638

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson is recalling the BD MAX Enteric Bacterial Panel (Catalog Number 442963) used with the BD MAX System due to false negative results when testing for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides. The recall affects 1,583 assay kits with lot numbers 8194784 and 8199682, both with an expiration date of February 22, 2020. The affected kits were distributed worldwide, including throughout numerous U.S. states (California, Georgia, Hawaii, Idaho, Michigan, Minnesota, Montana, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont, and Washington) and internationally to Australia, New Zealand, Canada, Europe, and Korea.

The false negative results mean the test could fail to detect these bacterial targets in patient samples, potentially leading to missed diagnoses. The source document does not specify what actions affected consumers or healthcare facilities should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

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. Quantity: 1583 assay kits Lot/code info: Lot number/UDI 8194784 (01)00382904429638 (17)200222(10)8194784(30)1 and 8199682 (01)00382904429638 (17)200222(10)8199682(30)1 Expiration Date: 2020-02-22

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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