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
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