—#46541

Product

ACCU-CHEK Complete blood glucose monitor, Ref. no. 516; Catalog nos. 03266770001 and 03871983001 with meter model no. 200 and Catalog no. 03871983001 with meter model number 250.

FDA product code: LFR — Glucose Dehydrogenase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K973662
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 bad strip.

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 #46541. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.