Jul

2003

Misys Healthcare Systems Class II

Company: Misys Healthcare Systems
Date of Enforcement Report: 7/30/03
Class: II

PRODUCT
Misys Laboratory System. Recall # Z-1007-03.

REASON
Software anomally. Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal disignations.

CODE
Versions 5.2, 5.23, and 5.3.

RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on June 10, 2003, and on June 13, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
467.

DISTRIBUTION
Nationwide, and Internationally.

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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Misys Healthcare Systems Class II

Amy Sellers

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