ACCU-CHEK Inform meter; catalog No. 3035123.
This recall has been terminated (originally issued December 28, 2004).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- November 19, 2004
- Posted
- December 28, 2004
- Terminated
- June 7, 2005
- Recall Number
- Z-0372-05
- Quantity
- 4697
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide.
Lot / Code Info
All units with firmware version 2.3 that have the OTE (other test entry) functionality enabled.
Root Cause
Other
Action Taken
Consignees were notified via a letter dated 11/19/04, which instructed them to discontinue using the OTE functionality.
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