Creatinine recall
Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on…
Why was Creatinine recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All
- Product
- Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on…
- Recalling firm
- Beckman Coulter Inc.
- 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.
- Recall date
- March 27, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)