SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Reported: December 29, 2021 Initiated: November 10, 2021 #Z-0399-2022
Product Description
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Reason for Recall
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.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 1433
- Distribution
- 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
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825. Recalled by Beckman Coulter Inc.. Units affected: 1433.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 29, 2021. Severity: Moderate. Recall number: Z-0399-2022.
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