Company: Roch Diagnostics
Product: Accu Check Inform Blood Glucose System
Class II
Date of Enforcement Report: 8/28/2002
All units that have ever displayed a temperature icon in conjunction with patient use.
Reason: May give erroneous results if the temperature icon has ever been displayed with use.
Manufacturer: Roch Diagnostics, Mannheim, Germany.
Recalled by: Roche Diagnostics Corporation, Indianapolis, IN, by visit on Aug. 2, 2002. Firm initiated recall is ongoing.
Distribution: Notionwide; 15,452 units were distributed.
Recall number: z-1268-2.
