Reported Dec 30, 2020 · Terminated
MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- MicroScan
- Pos MIC Panel Type 34 - Product UsageFor 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
- Lot codes and dates
- Catalog NumberB1017-216
- UDI Code(01)15099590657550(17)210610(11)200610(10)2021-06-10
- Lot Number2021-06-10
- Amount recalled
- 685 panel boxes (20 panels per box) = 13,700 panels
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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