03
Mar
2008

Cl II Sunquest Lab Blood Bank & Blood Donor

0

Company: Sunquest Information Systems, Inc.,
Date of Enforcement Report 2/11/2008
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 both the Blood Bank and Blood Donor modules, a problem has been identified in Blood Order Processing. The system does not trigger all Quality Assurances messages when reaction result grids are enabled. 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 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.

SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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

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