Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600, Manufactured by Bio-Rad Labora
FDA device recall Z-1041-2009 · posted 2009-03-24 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.
- Action taken
- An Urgent Medical Device Correction letter was sent out on October 17, 2008 via fax and phone call. The letter recommended that customers review the Summary Report for duplicate tube position numbers or barcode IDs within the same rack. If there are questions or a need for assistance, customers are to contact their regional Bio-Rad office. Follow-ups will be made once root cause is identified.
- Root cause
- Pending
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 92 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2008-10-17
- Date posted
- 2009-03-24
- Date terminated
- 2010-11-12
- 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 TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 (K063400) | Bio-Rad Laboratories, Inc. | 2006-12-01 |