Bio-Rad D-10 Dual Program Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test. This is a spe
FDA device recall Z-0376-2007 · posted 2007-01-25 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.
- Action taken
- The firm has issued phone calls and faxes to its US consignees starting 11/17/2006 and International notices began on 11/20/2006 explaining the reason for the recall and requesting the product be disposed.
- Root cause
- Other
- Status
- Terminated
- Product code
- JIT
- Quantity affected
- 900 kits, 43 sets distributed.
- Distribution
- Worldwide, including USA, India, Canada, France, Sweden, the UK, Hong Kong, Singapore, Germany, Brazil, Italy, China, Costa Rica and Panama.
- Date initiated
- 2006-11-17
- Date posted
- 2007-01-25
- Date terminated
- 2007-11-28
- 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 |
|---|---|---|
| BIO-RAD D-10 DUAL PROGRAM (K041444) | Bio-Rad Laboratories, Inc. | 2004-06-09 |