FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. (Distributed outside of the U.S.)
- Recall number
- Z-0426-06
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Roche brand Accu-Chek Aviva Meter (mmol/L); Catalog numbers 03532313001 and 03532321001. (Distributed outside of the U.S.)
- Status
- Terminated
- Initiated
- 2005-11-09
- Posted
- 2006-01-24
- Terminated
- 2007-06-14
- Reason
- Incorrect patient blood glucose test results may be reported due to a software problem.
- Root cause
- Other
- Action
- Notification letters dated 11/9/05 were issued to Users, Mail Order Distributors, Clinical Trial Sponsors, Pharmacists and Health Care Professionals. Press release issued 1/17/06.
- Quantity
- not on file
- Distribution
- Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.
- Lot, serial or model codes
- Aviva meter serial numbers 52600000000 through 52610999999, 52700000000 through 52710999999 and 52800000000 through 52810999999.
- 510(k) numbers
- ["K043474"]
- PMA numbers
- not on file
- Product code
- LFR
- 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