Z-0372-05

ACCU-CHEK Inform meter; catalog No. 3035123

Name: Z-0372-05 ACCU-CHEK Inform meter; catalog No. 3035123
Creator: Roche Diagnostics Corp.
Published: 2004-11-19
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2004-11-19 / Terminated / root cause: software

FDA source

Roche Diagnostics Corp. began a recall of ACCU-CHEK Inform meter; catalog No. 3035123 on 2004-11-19. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0372-05
Status: Terminated
Initiated: 2004-11-19
Posted: 2004-12-28
Terminated: 2005-06-07
Recalling firm: Roche Diagnostics GmbH
Product: ACCU-CHEK Inform meter; catalog No. 3035123.
Product code: NBW System, Test, Blood Glucose, Over The Counter
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.
Root cause tag: software
FDA root cause: Other
Action: Consignees were notified via a letter dated 11/19/04, which instructed them to discontinue using the OTE functionality.
Quantity in commerce: 4697
Distribution: Nationwide.
Product codes and lots: All units with firmware version 2.3 that have the OTE (other test entry) functionality enabled.

Product code NBW

K012210Class IIModification to Accu-Chek Inform MeterRoche Diagnostics Corp. / cleared 2001-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)