Z-0981-2019 Class II Terminated
FDA device recall Z-0981-2019 was initiated by Becton Dickinson & Co. on January 14, 2019 and is designated Class II. 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 Extende… The recall status is terminated (terminated April 3, 2020). Affected quantity: 1583 assay kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 13, 2019
- Initiation Date
- January 14, 2019
- Termination Date
- April 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1583 assay kits
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.
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 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.
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