ACCU-CHEK Compact Care Kit; catalog number 3149137.
FDA Recall Z-0977-05 · Posted 2005-07-12
Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeNBW
Date Initiated2005-05-18
Date Terminated2005-12-12
Reason for Recall
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.