BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic recall
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…
Why was BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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
- 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…
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 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.
- Recall date
- March 13, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)