Recall Z-0720-2021 · LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
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 and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes.
| Date | Dec 2, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | During the week of 12/01/2020, the Recalling Firm is sending an "URGENT MEDICAL DEVICE RECALL" Letter via e-mail and/or mail to customers informing them that 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. Customer are instructed to: 1. Discontinue use and discard, per their laboratory procedure/guidelines, a |
| Quantity | 685 panel boxes (20 panels per box) = 13,700 panels |
| 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¿Re |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043545 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) Dade Behring, Inc., Feb 17, 2005 |