Z-0399-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 29, 2021
- Initiation Date
- November 10, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1433
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.
Distribution Pattern
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
Code Information
Lot: M106450, UDI: 15099590575113