Roche Diagnostics Corp. ACCU-CHEK Inform meter; catalog No. 3035123. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ACCU-CHEK Inform meter; catalog No. 3035123.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units with firmware version 2.3 that have the OTE (other test entry) functionality enabled.
Products Sold
All units with firmware version 2.3 that have the OTE (other test entry) functionality enabled.
Roche Diagnostics Corp. is recalling ACCU-CHEK Inform meter; catalog No. 3035123. due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consignees were notified via a letter dated 11/19/04, which instructed them to discontinue using the OTE functionality.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026