24
Apr
2002

Sunquest Information Systems Inc. Class II

0

Company: Sunquest Information Systems, Inc
Date of Enforcement Report: 4/24/02
Class: II

PRODUCT
Misys Laboratory for Windows version 5.3. Recall # Z-0888-2.

CODE
REASON
Software QA code of BOTH for patient sex can result in QA flags not being generated for abnormal results.

Versions 5.3.

RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., aka Misys Healthcare Systems Tucson,
AZ, by a temporary procedural workaround March 8, 2002.Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
345.

DISTRIBUTION
Nationwide, internationally to United Kingdom, Ireland, Denmark, Canada, Bermuda and Saudi Arabia.

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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