Misys Healthcare Systems Class II

Company: Misys Healthcare Systems,
Date of Enforcement Report: 7/6/05
Class: II

PRODUCT
Misys Laboratory with Lab Access Results application for versions 5.3 and later. Recall # Z-0938-05

REASON
Software anomaly may rarely allow modification of previously reported specimen results.

CODE
Versions 5.3 and later

RECALLING FIRM/MANUFACTURER
Misys Healthcare Systems, Tucson, AZ, by fax on May 13, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
258 units

DISTRIBUTION
Nationwide and Internationally

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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Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.