BD MAX Enteric Bacterial Panel Recalled for False Negative Results
Becton Dickinson is recalling 1,583 BD MAX Enteric Bacterial Panel kits due to false negative results for specific bacterial targets.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (false negative diagnostic results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Becton Dickinson & Co. is recalling 1,583 units of the BD MAX Enteric Bacterial Panel (Catalog Number 442963). The recall is due to the potential for false negative results when testing specifically for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides targets.
The affected products are identified by lot numbers 8194784 and 8199682, with an expiration date of February 22, 2020. The agency classifies this as a Class II recall. Distribution was worldwide, including the United States (nationwide) and specific countries such as Australia, New Zealand, Canada, Europe, and Korea.
Healthcare facilities and laboratories should stop using the affected kits and contact Becton Dickinson for further instructions. This recall addresses a diagnostic accuracy issue rather than a physical safety hazard like fire or injury.
The recalled product
- Product
- 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 ent
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 1,583
Distribution
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