Beckman Coulter recalls MicroScan Pos MIC Panel Type 34 due to potential false elevated MIC results for daptomycin testing, affecting clinical isolate accuracy. Affected units may require replacement.
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.
Beckman Coulter is recalling MicroScan Pos MIC Panel Type 34 because some units may give false high results for daptomycin testing, which could lead to incorrect antibiotic treatment decisions. This is a quality control issue that affects lab testing accuracy.
The panel may produce false elevated minimum inhibitory concentration (MIC) values for daptomycin when testing certain bacterial strains. This could lead to incorrect antibiotic dosing decisions if the false high results are not recognized.
Laboratories using the MicroScan Pos MIC Panel Type 34 for antimicrobial susceptibility testing may be affected. Clinicians relying on these results for daptomycin treatment decisions are at risk of potential errors.
Check for the lot number 2021-06-10 on the panel. The product is sold under catalog number B1017-216 with UDI code (01)15099590657550(17)210610(11)200610(10)2021-06-10.
Look for the lot number 2021-06-10 on the MicroScan Pos MIC Panel Type 34.
Beckman Coulter confirmed that a portion of the affected product lot failed quality control for ATCC E. Faecalis 29212 versus daptomycin, potentially causing false elevated MIC results for clinical isolates.
False elevated MIC results could lead to incorrect antibiotic treatment decisions if the panel is used without recognizing the potential error.
Check for the lot number 2021-06-10 on the panel, which is associated with catalog number B1017-216 and UDI code (01)15099590657550(17)210610(11)200610(10)2021-06-10.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0720-2021 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0720-2021 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
