—#39416

Product

ACCU-CHEK Compact Care Kit; catalog number 3149137.

FDA product code: NBW — System, Test, Blood Glucose, Over The Counter
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K022171
Affected lot / code info: All units.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2005-05-18
Posted by FDA: 2005-07-12
Terminated: 2005-12-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #39416. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.