Recall Z-2889-2011 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories Inc
D-10 Dual Program Reorder Pack; contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibrator 1 & 2. Bio-Rad Laboratories Inc. Hercules, CA. Product Usage: Short Proghram: D-10 Dual Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). Extended Program: The Bio-
| Date | Jul 27, 2011 (initiated Jul 11, 2011) |
| Status | Terminated |
| Reason | Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435. |
| Root cause | Other |
| Action | Bio-Rad Laboratories Inc sent "URGENT: MEDICAL DEVICE CORRECTION" letters to all affected D-10 Dual customers and Bio-Rad subsidiaries on July 11, 2011 via FedEx or fax. The letters identified the product, the problem, and the action needed to be taken. The letters ask that inventory be examined and affected reorder pack lots be quarantined and destroyed according to local, state and federal regulations. All D-10 Dual customers were instructed to review their chromatograms generated from these lots. If the calibration has passed with good chromatography, the controls are within specification |
| Quantity | 418 |
| Distribution | Worldwide -- USA (nationwide) including the states of: AR, CA, CT, FL, HI, IN, MD, MN, MO, MS, NJ, NY, OH, PA, RI, TX. and the countries of: Brazil, Canada, China, England, France, India, Italy, Mexico, New Zealand, and S. Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041444 | BIO-RAD D-10 DUAL PROGRAM Bio-Rad Laboratories, Inc., Jun 9, 2004 |