Recall Z-1365-06 ยท LFR Glucose Dehydrogenase, Glucose
Roche Diagnostics Corp.
ACCU-CHEK HQ for Blood Glucose Monitoring and Automated Data Management and Communication; Contents include two Accu-Chek Advantage monitors including Cat. no. 2138018 and Cat. no. 2138026. Ref. nos. 12138018001 and 12218542001 both include include meters with model number 777.
| 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
| K983047 | ACCU-CHEK HQ SYSTEM Boehringer Mannheim Corp., Feb 5, 1999 |