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Beckman Coulter Inc. Recall: MicroScan Pos MIC Panel Type 34 - Product Usage: For the dete

Beckman Coulter Inc. Recall: MicroScan Pos MIC Panel Type 34 - Product Usage: For the dete is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Beckman Coulter Inc.; Product: MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or

Recalling firmBeckman Coulter Inc.
ProductMicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.
Reason for recallDue to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionU.S. Nationwide distribution including in the states of AL, AZ, CA, FL, IN, KY, MA, MI, MO, NC, NH, NY, OH, OK, PA, SC, SD, TN, TX, VA, and WI. The countries of Australia, Austria, Bahamas, Bangladesh, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Re
Recall initiated20201202
Recall numberZ-0720-2021
Categorydevice
StateCA
CountryUnited States

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