FDA Device

ACCU-CHEK Inform meter; catalog No. 3035123.

Hazard

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.

What You Should Do

Remedy

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

Products

ACCU-CHEK Inform meter; catalog No. 3035123.
Brand
Roche Diagnostics Corp.
UPC
All units with firmware version 2.3 that have the OTE (other test entry) functionality enabled.

Units Affected

4697