Device 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.
Z-0958-2013
Product summary
- Event
- Event 64162
- Status
- Terminated
- Classification
- Class II
- Quantity
- 57,962 units (50,452 units in the US)
- Official record key
device-enforcement:Z-0958-2013
Official wording
Reason: 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.
Code information: All
Distribution pattern: Worldwide Distribution - USA Nationwide and the countries of: Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica.
Derived failure modes
-
Unknown
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.