Recall Z-1363-06 ยท LFR Glucose Dehydrogenase, Glucose
Roche Diagnostics Corp.
ACCU-CHEK Complete diabetes monitoring kit/ care kit/ insulin pump therapy kit, Cat. no 515; Ref. nos. 03144852001 and 12031981001 with meter model no. 200 and Ref. no. 03144852001 with meter model no. 250.
| Date | Aug 5, 2006 (initiated Jun 22, 2006) |
| Status | Terminated |
| Reason | The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip. |
| Root cause | Other |
| Action | A recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available. |
| Quantity | 55,189 meters (for all Recalls Z-1354-1371-06) |
| Distribution | Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973662 | ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS Boehringer Mannheim Corp., Dec 15, 1997 |