VARIANT II Link Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, For the determination of Hemoglobin A1c in human w
FDA device recall Z-0399-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Reason for recall
- It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point.
- Action taken
- Bio-Rad Laboratories, Inc. sent a Medical Device Correction Notification letter dated October 25, 2011, via Federal Express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The correction was initiated by the firm, customers were instructed to contact their regional Bio-Rad office for any questions. For questions regarding this recall call 510-741-6114.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KRZ
- Quantity affected
- 63
- Distribution
- Nationwide Distribution including MI, SC, OH, IL, MN, MD, VA, NY and WI.
- Date initiated
- 2011-10-25
- Date posted
- 2012-01-11
- Date terminated
- 2012-02-02
- 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 LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, (K070819) | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2007-06-25 |