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BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use… recallZ-0981-2019 · Becton Dickinson & Co. · initiated Jan 14, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0981-2019
Status
Terminated
Initiated by the company
Jan 14, 2019
Recalling firm
Becton Dickinson & Co.
Quantity
1583 assay kits
Product code
PIC
FDA submissions
K140111
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 description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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