FDA-Device2021-12-29Class II
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Beckman Coulter Inc.
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.
Sold states
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
Affected count
1433
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0399-2022Don't want to check this manually?
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