Reported Dec 29, 2021 · Ongoing
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
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?
- SYNCHRON Systems Cholesterol (CHOL) Reagent
- REF467825
- Lot codes and dates
- LotM106450
- UDI15099590575113
- Amount recalled
- 1433
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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