FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: ACCU-CHEK Inform meter; catalog No. 3035123.
- Recall number
- Z-0372-05
- Recalling firm
- Roche Diagnostics Corp.
- Product
- ACCU-CHEK Inform meter; catalog No. 3035123.
- Status
- Terminated
- Initiated
- 2004-11-19
- Posted
- 2004-12-28
- Terminated
- 2005-06-07
- Reason
- 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
- Other
- Action
- Consignees were notified via a letter dated 11/19/04, which instructed them to discontinue using the OTE functionality.
- Quantity
- 4697
- Distribution
- Nationwide.
- Lot, serial or model codes
- All units with firmware version 2.3 that have the OTE (other test entry) functionality enabled.
- 510(k) numbers
- ["K012210"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28