ACCU-CHEK Inform meter; catalog No. 3035123.
FDA Recall Z-0372-05 · Posted 2004-12-28
Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeNBW
Date Initiated2004-11-19
Date Terminated2005-06-07
Product Quantity4697
Reason for Recall
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.
Firm Action
Consignees were notified via a letter dated 11/19/04, which instructed them to discontinue using the OTE functionality.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.