Oct

2002

Beckman Coulter Inc. Class II

Company: Misys Healthcare Systems, Inc
Date of Enforcement Report: 10/9/02
Class: II

PRODUCT
Cytomics RXP software. Recall # Z-1387-2.

REASON
When analyzing multiple listmode files using a multi-file analysis protocol, incorrect percentage results may occur if “% in Regions” is selected.

CODE
Version 1.0.

RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA, by letters dated May 15, 2002. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6.

DISTRIBUTION
IL, Germany and Canada.

About the author

Amy Sellers

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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Beckman Coulter Inc. Class II

Amy Sellers

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