Z-0417-06

Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the U.S.)

Name: Z-0417-06 Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the U.S.)
Creator: Roche Diagnostics Corp.
Published: 2005-11-09
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2005-11-09 / Terminated / root cause: software

FDA source

Roche Diagnostics Corp. began a recall of Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the U.S.) on 2005-11-09. The reason FDA records is "Incorrect patient blood glucose test results may be reported due to a software problem". 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-0417-06
Status: Terminated
Initiated: 2005-11-09
Posted: 2006-01-24
Terminated: 2007-06-14
Recalling firm: Roche Diagnostics GmbH
Product: Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the U.S.)
Product code: LFR Glucose Dehydrogenase, Glucose
Reason for recall: Incorrect patient blood glucose test results may be reported due to a software problem.
Root cause tag: software
FDA 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.
Distribution: Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.
Product codes and lots: Aviva meter serial numbers 52500000000 through 52510999999.

Product code LFR

K043474Class IIAccu-Chek Aviva SystemRoche Diagnostics Corp. / cleared 2005-04-27

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)