Z-2599-2018 Class II Terminated

Recalled by Beckman Coulter Inc. — Brea, CA

Recall Details

Product Type
Devices
Report Date
August 8, 2018
Initiation Date
May 4, 2018
Termination Date
August 7, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
686 boxes

Product Description

MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

Reason for Recall

The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported.

Distribution Pattern

NJ, TX, IA, PA, FL, NE, OH, NY, CA, MO, OK, LA

Code Information

Lot 2018-11-03