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Beckman Coulter Inc. recalls SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Recalled December 29, 2021 · FDA recall Z-0399-2022 · Beckman Coulter
Hazard
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. · FDA Class II
Units
1433
Sold at
US Nationwide distribution in the states of Louisiana, Ohio, North Carolina, California, South Carolina, Oklahoma, Pennsylvania, New York, Florida, New Jersey, Wisconsin, Alabama, Texas, Georgia, Maine, North Dakota, Virginia, Kansas, Washington, New Mexico, Iowa ,Nebraska, Idaho, Michigan, Maryland, Arizona, Hawaii, Missouri, Oregon, Mississippi, Rhode Island, Alaska, Tennessee, Illinois, Delaware, Kentucky, Arkansas, West Virginia, Massachusetts. OUS: India, South Africa, Saudi Arabia, Canada, Lebanon, Singapore, Philippines, Thailand
Description
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.
Product
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →