BD MAX Enteric Bacterial Panel Recall: False Negative Results for ETEC and Plesiomonas
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.
Lower-risk 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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/69124-bd-max-enteric-bacterial-panel-recall-false-negative-results-for.
Source Summary by GovInfoNow · govinfonow.com/recall/69124-bd-max-enteric-bacterial-panel-recall-false-negative-results-for · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0981-2019
Cite this page
“BD MAX Enteric Bacterial Panel Recall: False Negative Results for ETEC and Plesiomonas.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69124-bd-max-enteric-bacterial-panel-recall-false-negative-results-for. Based on FDA recall #Z-0981-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0981-2019%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Becton Dickinson- Product
BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX- Category
Medical device
What to do — step by step
Check Panel Lot Number
Look for lot numbers 8194784 or 8199682 on the panel's label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 17 states.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Georgia, Hawaii, Idaho, Michigan, Minnesota, Montana, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Vermont, Virginia, Washington.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
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.
- Official source: FDA Recall #Z-0981-2019 (January 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0981-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.