Recall Z-0372-05 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diagnostics Corp.
ACCU-CHEK Inform meter; catalog No. 3035123.
| Date | Dec 28, 2004 (initiated Nov 19, 2004) |
| Status | Terminated |
| Reason | A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa. |
| Root cause | Other |
| Action | Consignees were notified via a letter dated 11/19/04, which instructed them to discontinue using the OTE functionality. |
| Quantity | 4697 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012210 | MODIFICATION TO ACCU-CHEK INFORM METER Roche Diagnostics Corp., Aug 9, 2001 |