Sunquest LIS

Company: Sunquest Information Systems, Inc.
Date of Enforcement Report: 3/7/01
Date of Recall: 1/15/01
Class: II


Flexilab Laboratory Information System (not for use in blood banks).
Recall #Z-0369-1.


Software anomaly allows misprint of patient information.


Flexilab version 5.23 with RBR module.


Sunquest Information Systems, Inc., Tucson, AZ.


Manufacturer, by fax on January 15, 2001. Firm-initiated recall ongoing.


WI, WA, MI, VA, NM, OH, AZ, and Denmark.


15 laboratories.

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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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