SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Check against the official notice below — it lists the full affected range.
Beckman Coulter Inc. is recalling SYNCHRON Systems Cholesterol (CHOL) Reagent, Lot M106450, due to potential malfunctions that may cause calibration failures and quality control errors. The reagent may display Out of Calibration Range Low (OCR Low) or Back to Back (B/B) errors, and brown particulates may be visible in compartment C of the reagent cartridge. If used despite these issues, the reagent could produce erroneous low cholesterol patient results and failed quality control and calibration tests. The affected lot was distributed nationwide across 43 states and Washington D.C., with 1,433 units recalled.
The recall record does not specify what affected consumers or healthcare facilities should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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, Delawar Quantity: 1433 Lot/code info: Lot: M106450, UDI: 15099590575113
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.