Recall Z-0958-2013 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
Beckman Coulter Inc.
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.
| Date | Mar 15, 2013 (initiated Dec 28, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Labeling design |
| Action | Beckman Coulter sent an Urgent Product Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed the customers that 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. Customers are instructed to complete and return the enclosed response form. Customers with questions about the notification letter are instructed to contact the call center (hotlin |
| Quantity | 57,962 units (50,452 units in the US) |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of: Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica. |
| FDA record | Open on fda.gov |