Beckman Coulter recalls SYNCHRON Cholesterol reagent REF 467825 due to potential errors causing inaccurate cholesterol test results. Affected units may show brown particles or calibration failures.
Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.
Beckman Coulter is recalling SYNCHRON Systems cholesterol reagents that may cause inaccurate test results. Using these reagents could lead to wrong cholesterol readings, which might affect patient care.
The reagent may show brown particles in compartment C and fail calibration tests. This can cause cholesterol test results to be too low, leading to potential misdiagnosis.
Lab users who test cholesterol with SYNCHRON Systems reagents REF 467825 are affected. Those using the reagents for patient testing are most at risk of incorrect results.
Check for reagent lot number M106450 or unique identifier 15099590575113. The product is labeled SYNCHRON Systems Cholesterol (CHOL) Reagent REF 467825.
Verify the lot number (M106450) and unique identifier (15099590575113) on the reagent packaging.
The reagent may cause inaccurate cholesterol test results due to calibration failures and brown particles in compartment C.
The official recall notice does not specify a remedy, so contact Beckman Coulter for guidance.
Check for lot number M106450 or unique identifier 15099590575113 on the reagent packaging.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0399-2022 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0399-2022 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.
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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.
