CLASS II Device recall · Reported 13 Mar 2019 · FDA Enforcement Report
BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use recalled
Becton Dickinson & is recalling BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System, distributed nationwide in the US. The recall was initiated on 14 Jan 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0981-2019
- FDA event ID
- 82046
- Recalling firm
- Becton Dickinson &, Sparks, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jan 2019
- FDA classified
- 6 Mar 2019
- Reported
- 13 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- E. coli
- Device type
- Test Kits & Diagnostics
Timeline
| 14 Jan 2019 | Recall initiated by company | |
| 6 Mar 2019 | Classified by FDA | +51 days |
| 13 Mar 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide CaliforniaGeorgiaHawaiiIdahoMichiganMinnesotaMontanaNew JerseyNew MexicoOhioOregonPennsylvaniaSouth CarolinaTexasVirginiaVermontWashington
Questions about this recall
Is BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System recalled?
Yes. Becton Dickinson & recalled BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System on 14 Jan 2019. The recall is Class II and its status is Terminated. Recall number Z-0981-2019.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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