01
May
2002

Hitachi Ltd Class II

0

Company: Hitachi Ltd
Date of Enforcement Report: 5/1/02
Class: II

PRODUCT
Roche Modular Analytics immunoassay based clinical chemistry analyzer, model E170, catalog number 7656961. Recall # Z-0922-2.

REASON
Possibility of false negative and false positive results being reported.

CODE
All units with software version 01-03.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated March 27, 2002.

MANUFATURER: Hitachi Ltd., Kbaraki-ken, Japan.
Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
76.

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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