Beckman Coulter Inc.: MicroScan 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

Is my product affected?

MicroScan 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.

• UPC 15099590657550

Check against the official notice below — it lists the full affected range.

What happened

Beckman Coulter Inc. is recalling MicroScan Pos MIC Panel Type 34 products used to identify bacteria and test their resistance to antimicrobial agents. A customer report and internal investigation confirmed that a portion of the affected product lot failed quality control testing for E. Faecalis bacteria when tested against the antibiotic daptomycin. The problem is that some panels may produce falsely elevated results for daptomycin resistance in clinical samples, even when the quality control results appear normal.

The recall affects 13,700 panels (685 boxes containing 20 panels each) with Catalog Number B1017-216 and Lot Number 2021-06-10. The affected product was distributed nationwide across the United States and internationally to multiple countries including Canada, Australia, France, Germany, India, Brazil, and others. The recall source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Due 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.

Details from the source

Reason for recall: Due 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. Distribution: U.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¿Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, India, Iran, Ireland, Is Quantity: 685 panel boxes (20 panels per box) = 13,700 panels Lot/code info: Catalog Number: B1017-216 UDI Code: (01)15099590657550(17)210610(11)200610(10)2021-06-10 Lot Number: 2021-06-10

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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