—#42790

Product

Roche brand Accu-Chek Aviva Care Kit; Catalog number 04422058170; - Canada Catalog number 04422058164; - Nordics Catalog number 04422040170. (Distributed outside of the U.S.)

FDA product code: LFR — Glucose Dehydrogenase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K043474
Affected lot / code info: Aviva meter serial numbers 52600000000 through 52610999999, 52700000000 through 52710999999 and 52800000000 through 52810999999.

Why it was recalled

Incorrect patient blood glucose test results may be reported due to a software problem.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide, Belgium, Canada, Germany, Netherlands, Spain and Sweden.

Timeline

Recall initiated: 2005-11-09
Posted by FDA: 2006-01-24
Terminated: 2007-06-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42790. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.