Recall Z-0385-2014 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diagnostics Operations, Inc.
ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
| Date | Nov 22, 2013 (initiated Oct 25, 2013) |
| Status | Terminated |
| Reason | There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when the Manual Pump option is chosen on the ACCU-CHEK Aviva Combo meter, there is a possibility of receiving an incorrect bolus advice recommendation that may cause a temporary under delivery of insulin. |
| Root cause | Software design |
| Action | The firm, Roche Diagnostics, sent an "URGENT MEDICAL DEVICE CORRECTION (UMDC)" letter dated October 29, 2013, via UPS to their consignees/customers. The letter described the product, problem and actions to be taken. The UMDC informed them of the software synchronization issue with the ACCU-CHEK Combo system that may cause a temporary under delivery of insulin. The customers were instructed to ensure they properly deliver the correction bolus when utilizing the Manual Pump option, as instructed in the Owners Booklet; and complete and return the Business Reply Card via fax to 1-877-282-0223. Th |
| Quantity | 6,595 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111353 | ACCU-CHECK COMBO SYSTEM Roche Diagnostics, Jul 17, 2012 |