Roche brand Accu-Chek Aviva Pediatrics Kit; Catalog number 04593839001. (Distributed within the U.S.)
FDA Recall Z-0422-06 · Posted 2006-01-24
Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeLFR
Date Initiated2005-11-09
Date Terminated2007-06-14
Reason for Recall
Incorrect patient blood glucose test results may be reported due to a software problem.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.