Bio Rad brand VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, Model Number/Catalog No.: 270-2417, which contains t
FDA device recall Z-1342-2011 · posted 2011-02-17 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories Inc
- Reason for recall
- The firm received customer complaints associated with the Update Kit CD-ROM not being able to generate a valid calibration after being uploaded, resulting in patient results not being generated.
- Action taken
- Medical Device Correction letter dated March 24, 2010 was sent to customers. The letter identified the affected product and explained the reason for recall. Customers were asked to destroy Lot No. AA00190 and replace it with the Lot No. AA00838 CD-ROM that is enclosed with the letter. Customers are to complete and fax back the Medical Device Correction Response Form at the number provided.
- Root cause
- Other
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 48 units
- Distribution
- Worldwide Distribution -- USA and Italy.
- Date initiated
- 2010-03-24
- Date posted
- 2011-02-17
- Date terminated
- 2011-03-04
- 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 |
| VARIANT II HEMOGLOBIN A1C (K040872) | Bio-Rad Laboratories, Inc. | 2004-04-15 |