—#39124

Product

ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter.

FDA product code: NBW — System, Test, Blood Glucose, Over The Counter
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K040796
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 an undosed test strip is bent upwards, and held upwards, while the meter is waiting for the sample.

Root cause (FDA determination)

Other

Action the firm took

Recall letters dated 6/7/05 were sent to all customers. Distributors were requested to send a copy of the notification to all customers of test strips used with the product. Users are instructed to never operate the meter without the optics cover in place, and this information will be included in test strip boxes.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2005-06-07
Posted by FDA: 2005-08-13
Terminated: 2007-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #39124. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.