Recall Z-0422-06 ยท LFR Glucose Dehydrogenase, Glucose
Roche Diagnostics Corp.
Roche brand Accu-Chek Aviva Pediatrics Kit; Catalog number 04593839001. (Distributed within the U.S.)
| Date | Jan 24, 2006 (initiated Nov 9, 2005) |
| Status | Terminated |
| Reason | Incorrect patient blood glucose test results may be reported due to a software problem. |
| Root cause | Other |
| Action | Notification letters dated 11/9/05 were issued to Users, Mail Order Distributors, Clinical Trial Sponsors, Pharmacists and Health Care Professionals. Press release issued 1/17/06. |
| Distribution | Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043474 | ACCU-CHEK AVIVA SYSTEM Roche Diagnostics Corp., Apr 27, 2005 |