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.
FDA Recall Z-2599-2018 · Posted None
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Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeLTT
Date Initiated2018-05-04
Date Terminated2020-08-07
Product Quantity686 boxes
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.
Firm Action
A recall notification letter was sent the week of 05/01/2018 via email, mail, and phone if needed.
Root Cause
Labeling design
Distribution Pattern
NJ, TX, IA, PA, FL, NE, OH, NY, CA, MO, OK, LA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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