Recall Z-1969-2011 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories, Inc., Hercules, CA
Bio Rad brand D-10 Hemoglobin A1c Program Reorder Pack, which contains Update Kit D-10 A1c Program Diskette; Model Numbers: 220-0101 (Reorder Pack); 220-0115 (Program Diskette); Distributed and manufactured by: Bio-Rad Laboratories, Inc., Hercules, CA System Overview: The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative perc
| Date | Apr 13, 2011 (initiated Sep 8, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Distribution | Nationwide Distribution including : PA, OH, MO, CA, TX, FL, MA, MD, KY, OH, MI, NJ, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031043 | D-10 HEMOGLOBIN A1C Bio-Rad Laboratories, Inc., Aug 27, 2003 |