—#45754

Product

ACCU-CHEK Comfort Curve. Cat. No. 3149030; Ref. number 0314903001 with meter model number 2138930.

FDA product code: CGA — Glucose Oxidase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K930979
Affected lot / code info: All units.

Why it was recalled

The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error.

Root cause (FDA determination)

Other

Action the firm took

A recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46250-0416

Distribution

Distribution pattern: Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin Islands.

Timeline

Recall initiated: 2006-06-22
Posted by FDA: 2006-08-05
Terminated: 2008-04-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #45754. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.