Corrective action of Olympus System Reagent Cholesterol and HDL Cholesterol, Olympus
2004.12.15
Product group In-vitro diagnostics
Reference 02614/04
Olympus settles a field corrective action of Olympus System Reagent HDL Cholesterol (lot number 2908) and Olympus System Reagent Cholesterol (lot number 3020). The manufacturer observed that foaming in 120 ml vials was causing calibration failure with some vials. Foaming in some cases caused calibration failure. When calibration fails the system will not run the test. The manufacturer advised customers to handle reagents prior to use to prevent foaming.