Cl Il SunquestBlood Bank and Blood Donor Modules

Company: Sunquest Information Systems, Inc.,
Date of Enforcement Report 8/6/2008
Class:ll

PRODUCT
Sunquest Laboratory Blood Bank and Blood Donor Modules v5.2, Distributed with Sunquest Laboratory v5.3 and v5.4. and Sunquest Laboratory Blood Bank and Blood Donor Modules v6.0.1, v6.0.2 and v6.4.0 (Beta), Distributed with Sunquest Laboratory v6.1, v6.2, v6.3 and v6.3.1 (Beta), Recall # B-1137-08

REASON
Software, with a glitch or defect, was distributed.

RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc., Tucson, AZ, by e-mail on June 5, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
103 clients – Sunquest Blood Bank 5.2; 286 clients – Sunquest Blood Bank 6.0.1 and 6.0.2 and (Beta)

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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Or just email training@softwarecpr.com for more info.

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