16
Oct
2002

Roche Diagnostics Corp. Class II

0

Company: Roche Diagnostics Corp
Date of Enforcement Report: 10/16/02
Class: II

PRODUCT
Roche brand Elecsys 2010 clinical chemistry analyzers. Recall # Z-0005-3.

REASON
Possibile incorrect breast cancer marker results.

CODE
Serial numbers 1058-11, 1164-70 and 0806-10.
(All analyzers with software version 06-01.)

RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone on August 8, 2002.
Manufacturer: Hitachi Ltd., Instrument Division, Ibaraki-ken, Japan. Firm initiated recall ongoing.

VOLUME OF PRODUCT IN COMMERCE
3.

DISTRIBUTION
IL and WV.

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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