22
Dec
2004

Roche Diagnostics Corp Class II

0

Company: Roche Diagnostics Corp
Date of Enforcement Report: 12/22/04
Class: II

PRODUCT
MagNA Pure LC Instrument; catalog numbers 2236931 and 03670325001. Recall # Z-0297-05.

REASON
Test results may be adversely affected by software shutting down the cooling blocks in systems with software versions 3.09.

CODE
All systems using software version 3.09.

RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter dated November 5, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
65.

DISTRIBUTION
Nationwide.

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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IEC 29119-1 Software and System Testing

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