FDA recall Z-2599-2018

Product

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

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

Key facts

Status

Terminated

Initiation date

2018-05-04

Report date

2018-08-08

Termination date

2020-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2599-2018