17
Mar
2000

Roche Chemistry Analyzer 914 Class II

0

PRODUCT

Roche Hitachi 914 Chemistry Analyzer, used for diagnostic testing for
routine and specialty chemistry analytes. Recall #Z-613-0.

REASON

There is a potential for mismatch of sample identification information
and results on this version of software.

CODE

Catalog number 914000. All units with software version 3.0.

MANFACTURER/SOFTWARE SITE

Roche Diagnostic Corporation, Indianapolis, Indiana.

RECALLED BY

Manufacturer, by letter dated March 17, 2000. Firm-initiated field
correction ongoing.

DISTRIBUTION

Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii,
Indiana, Kansas, Michigan, Missouri, Nebraska, New Jersey, New York,
Ohio, Oklahoma, Pennsylvania, Puerto Rico and Texas.

QUANTITY

56 units were distributed

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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