Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine
FDA device recall Z-0958-2013 · posted 2013-03-15 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- 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.
- Action taken
- 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 (hotline) at (800) 854-3633 in the US and Canada.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- CGX
- Quantity affected
- 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.
- Date initiated
- 2012-12-28
- Date posted
- 2013-03-15
- Date terminated
- 2013-10-17
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS CREATININE REAGENT (K934361) | Olympus Corp. | 1993-11-16 |
| OLYMPUS CREATININE REAGENT (K924692) | Olympus Corp. | 1992-10-19 |