Feb

2008

Cl II Sunquest Lab-expanded recall

Company: Sunquest Information Systems, Inc.,
Date of Enforcement Report 1/23/2008
Class:ll

PRODUCT
Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2
Distributed with Sunquest Laboratory v6.1, v6.2 and v6.3

REASON
In the Sunquest Blood Bank and Blood Donor Modules, a problem has been identified in Blood Product Testing. If the user chooses to delete and unacceptable product test result by replacing it with another unacceptable product test result, then cancels and saves, the system incorrectly retains the initial result instead of leaving the product test pending. The problem only occurs in specialized situations. Customers are asked to request the software correction via the Client support Webpage.

RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc.
Tucson, Arizona

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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Cl II Sunquest Lab-expanded recall

Amy Sellers

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