24
Sep
2008

Cl Il Sunquest version 6.0.1 and 6.0.2

0

Company: Sunquest Information Systems, Inc.,
Date of Enforcement Report 9/24/2008
Class:ll

PRODUCT
Sunquest Blood Bank and Blood Donor version 6.0.1 distributed with Sunquest Laboratory 6.1 and 6.2; Sunquest Blood Bank and Blood Donor version 6.0.2 distributed with Sunquest Laboratory 6.3, Recall # B-2052-08

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

RECALLING FIRM/MANUFACTURER
Sunquest Information Systems, Inc, Tucson, AZ, by e-mail on August 15, 2008. Firm initiated recall is ongoing..

VOLUME OF PRODUCT IN COMMERCE
273 clients Nationwide and 12 Internationally

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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