—#35939

Product

ACCU-CHEK Inform meter; catalog No. 3035123.

FDA product code: NBW — System, Test, Blood Glucose, Over The Counter
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K012210
Affected lot / code info: All units with firmware version 2.3 that have the OTE (other test entry) functionality enabled.

Why it was recalled

A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified via a letter dated 11/19/04, which instructed them to discontinue using the OTE functionality.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2004-11-19
Posted by FDA: 2004-12-28
Terminated: 2005-06-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35939. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.