Becton Dickinson recalls BD MAX Enteric Bacterial Panel (Catalog 442963) due to false negative results when testing for ETEC and Plesiomonas shigelloides. Affected units may not detect infections accurately.
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.
Becton Dickinson is recalling its BD MAX Enteric Bacterial Panel (Catalog Number 4:42963) because it can give false negative results when testing for specific bacteria like ETEC and Plesiomonas shigelloides. This means the test might miss infections, leading to incorrect health conclusions.
The panel can produce false negative results when testing for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides. This means infections might go undetected, potentially leading to incorrect health decisions.
Healthcare professionals using the BD MAX Enteric Bacterial Panel for in vitro diagnostic testing are most at risk. The recall affects specific lot numbers and expiration dates.
Check for the catalog number 442963 on the BD MAX Enteric Bacterial Panel. Affected units have specific lot numbers: 8194784 and 8199682, with an expiration date of February 22, 2020.
Look for lot numbers 8194784 or 8199682 on the panel's label.
The panel can give false negative results when testing for ETEC and Plesiomonas shigelloides, which could lead to missed infections.
Check the lot number on the panel. If it matches 8194784 or 8199682, contact Becton Dickinson for guidance.
The recall record does not mention a remedy or fix for the false negative results.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-0981-2019 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-0981-2019 from Becton Dickinson. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
