medical Class II Updated 2021-12-29

Beckman Coulter Inc. recalls SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825

Recalled Product

SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: M106450, UDI: 15099590575113
View official government recall

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