FDA-Device2013-03-27Class II
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.
Beckman Coulter Inc.
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.
Sold states
Worldwide Distribution - USA Nationwide and the countries of: Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica.
Affected count
57,962 units (50,452 units in the US)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0958-2013Don't want to check this manually?
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