Recall Z-0965-2014 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories, Inc.
D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. United States; Bio-Rad Laboratories, Hercules, CA 94547 The Bio-Rad D-10 Hemoglobin Testing System provides an integrated method for the separation and determination of the relative percent of specific hemoglobins (e.g., A2, F, Ale} in whole blood. The separation is based on the principles of high performance liquid chromato
| Date | Feb 10, 2014 (initiated Nov 22, 2013) |
| Status | Terminated |
| Reason | D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System. |
| Root cause | Software design |
| Action | BIO-RAD sent an Urgent Medical Device Correction letter dated November 22, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue to use the affected update kit disk(s) included with the reorder pack(s), but manually track the number of injections on the cartridge, reviewing QC results closely throughout the life of the reorder pack or destroy the affected disk(s) included with these reorder pack(s) and replace with the new Update Kit disk(s) The new Update Kit disks will elminate the |
| Quantity | 2906 kits (318 Kits in US; 2588 kits internationally) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Latin America, Asia Pacific, Canada, Australia, New Zealand and India. |
| 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 |