Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbe
FDA device recall Z-1969-2011 · posted 2011-04-13 · Terminated
Recall details
- Recalling firm
- Bio-Rad Laboratories, Inc., Hercules, CA
- Reason for recall
- The firm discovered that the Update Kit Floppy Diskette included in the reorder pack was mislabeled with an incorrect Lot Number for the Calibrator/Diluent Set as: S01819; The correct Lot Number for the Calibrator/Diluent Set is: S01704.
- Action taken
- The Bio-Rad Laboratories, Inc, sent a Medical Device Correction letter dated 9/8/10, to all affected customers via Federal Express addressing this mislabeling issue, a new Update Kit Floppy Diskette, Lot No. BA02210 has been produced, and Bio-Rad requests that you please destroy the Lot No. AA01815. If you have any questions please contact your regional Bio-Rad office. You may also call (510) 724-7000.
- Root cause
- Other
- Status
- Terminated
- Product code
- LCP
- Distribution
- Nationwide Distribution including : PA, OH, MO, CA, TX, FL, MA, MD, KY, OH, MI, NJ, and WA.
- Date initiated
- 2010-09-08
- Date posted
- 2011-04-13
- Date terminated
- 2011-06-29
- Location
- Hercules, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| D-10 HEMOGLOBIN A1C (K031043) | Bio-Rad Laboratories, Inc. | 2003-08-27 |