VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600; Product is manufa
FDA device recall Z-1902-2010 · posted 2010-06-25 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- Sample test results for the first run appears to be correct but all subsequent results during that run were assigned incorrect barcode and tube position.
- Action taken
- Bio-Rad Laboratories, Inc. issued and "Urgent: Medical Device Correction" dated January 22, 2009 to all affected consignees by FED EX, followed up by telephone calls for those not responding. Consignees were instructed on proper steps to take in dealing with the affected product. Further communication will follow to provide a solution. For further information, contact Bio-Rad Laboratories at 1-510-724-7000.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LCP
- Distribution
- Worldwide Distribution -- United States, Argentina, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, New Zealan
- Date initiated
- 2009-01-22
- Date posted
- 2010-06-25
- Date terminated
- 2011-03-22
- Location
- Hercules, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIANT II HEMOGLOBIN A1C PROGRAM (K984268) | Bio-Rad | 1998-12-17 |