Aug

2002

Roch Diagnostics Class II

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Amy Sellers

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