MicroScan Pos Combo Panel Type 43 recalled over Listeria risk

Recall date

May 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Beckman Coulter Inc. recalls MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility an…

Recall number

Z-2599-2018

FDA classification

Class II

Brand / firm

Beckman Coulter Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.