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Terminated

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

FDA Recall Z-0417-06 · 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.

K043474ACCU-CHEK AVIVA SYSTEMRoche Diagnostics Corp. · 2005-04-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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