—#45752

Product

ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 3332586; Ref. no. 03332586001 with meter model no. 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 the test strip may be damaged or test was not performed correctly.

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 #45752. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.