Recall Z-0979-05 ยท CGA Glucose Oxidase, Glucose
Roche Diagnostics Corp.
ACCU-CHEK Instant Care Kit; Catalog number 91490.
| Date | Jul 13, 2005 (initiated May 18, 2005) |
| Status | Terminated |
| Reason | The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip opening has been previously flooded with excess control solution or blood. |
| Root cause | Other |
| Action | A recall letter dated 5/18/05 was sent to health care professionals informing them of the problem and reqeusting them to provide a letter to their patients alerting them to the issue and how to avoid it. A notice of the problem will be placed in all packages of strips in the future. |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952875 | ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS Boehringer Mannheim Corp., Nov 21, 1995 |