—#165211

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.

FDA product code: LTT — Panels, Test, Susceptibility, Antimicrobial
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K020160
Affected lot / code info: Lot 2018-11-03

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.

Root cause (FDA determination)

Labeling design

Action the firm took

A recall notification letter was sent the week of 05/01/2018 via email, mail, and phone if needed.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

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

Timeline

Recall initiated: 2018-05-04
Terminated: 2020-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165211. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.