05
Jan
2012

Cl ll cobas c 311 Analyzer

0

Company:Roche Diagnostics Operations, Inc.
Date of Enforcement Report 1/4/12
Class ll:

PRODUCT
cobas c 311 Analyzer, Part Number: 04826876001 In-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride. Recall # Z-0310-2012

REASON
The cobas c 311 analyzer software may incorrectly calculate the volume of the ISE Reference Electrolyte solution remaining on the analyzer. In some cases the incorrect results obtained will not be flagged with any data alarms.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter on October 26, 2011.
Manufacturer: MHitachi High-Technologies Corp., Tokyo, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
940 units

DISTRIBUTION
Nationwide and Internationally

About the author

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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