Becton Dickinson & Co.: Medical Device Recall in 2019 - (Recall #: Z-0981-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 14, 2019

Date Posted: March 13, 2019

Recall Number: Z-0981-2019

Event ID: 82046

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.

Status: Terminated

Product Quantity: 1583 assay kits

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated