Z-0981-2019Class II

BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The...

Name: Z-0981-2019 BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The...
Creator: Becton Dickinson & Co.
Published: 2019-01-14
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-01-14 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of 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... on 2019-01-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0981-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-14
Posted: 2019-03-06
Terminated: 2020-04-03
Recalling firm: Becton Dickinson & Co
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 enteric bacterial pathogens.
Product code: PIC Oral Electronic Vision Aid
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: BD Diagnostic Systems issued "URGENT MEDICAL DEVICE PRODUCT ADVISORY" Customer letters via UPS on January 14, 2019. The letters described the product, problem, and actions to take. The customers were instructed to do the following: 1. Complete the attached Customer Response Form and return to BD Regulatory Compliance at Email: [email protected] or Fax to: No.: 410-316-4258 whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 2. Although prevalence rates are considered to be low, if no other cause of enteric infection is determined you may choose to confirm any negative result for Enterotoxigenic Escherichia coli (ETEC) and Plesiomonas shigelloides obtained using the BD MAX Extended Enteric Bacterial Panel assay using an alternate method or using sample buffer tubes from a lot of EBP not listed above. Note that treatment for these infections is mainly supportive and antibiotics are not commonly used except in severe cases. 3. If your laboratory uses the xEBP assay and you would like replacement of your EBP kit(s), please complete the acknowledgement form included in the letter and return it via the instructions on the form. 4. Share this Advisory Letter with all users of the BD MAX instrument within your facility to ensure awareness. BD will provide replacement upon request using the Customer Response form. If you require further assistance, please contact: BD Customer/Technical Support 800-638-8663 Monday Friday between 7:00am and 7:00pm (EST) in the United States.
Quantity in commerce: 1583 assay kits
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0981-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0981-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-06

Product code PIC

K140111Class IIBd Max(tm) Enteric Bacterial Panel;bd Max(tm) InstrumentBecton, Dickinson and Company / cleared 2014-05-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)