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Beckman Coulter Inc. recalls Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of C
Recalled March 27, 2013 · FDA recall Z-0958-2013 · Beckman Coulter
Hazard
Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance. · FDA Class II
Units
57,962 units (50,452 units in the US)
Sold at
Worldwide Distribution - USA Nationwide and the countries of: Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica.
Description
Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance.
Product
Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →