Recall Z-0977-05 ยท NBW System, Test, Blood Glucose, Over The Counter
Roche Diagnostics Corp.
ACCU-CHEK Compact Care Kit; catalog number 3149137.
| Date | Jul 12, 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 the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for the sample, or if excess control solution or blood has been applied to the test strip. |
| 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
| K022171 | ACCU-CHEK COMPACT SYSTEM Roche Diagnostics Corp., Jul 23, 2002 |