Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest

FDA device recall Z-2332-2012 · posted 2012-09-07 · Terminated

Recall details

Recalling firm

Sunquest Information Systems, Inc.

Reason for recall

Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the Windows-based merge application is used and the "Event merge across patients" option is used, a receiving system (for example a HIS or CoPath system) may interpret the event merge as a full patient merge. This occurs because a trigger from the Laboratory system for the event

Action taken

The firm, Sunquest, sent an "Urgent- Product Safety Notice: PSN-12-02" dated March 15, 2012 to all their customers who purchased the Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1. The notice described the product, the problems and the actions to be taken. Customers were instructed to request the software correction by creating a Case via the Client Support webpage at: www.sunquestinfo.com/supportweb. Customers with questions were instructed to contact Client support at (877) 239-6337 for US and Canadian Sites and at +44 (0) 161 335 0562 for international sites.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

126 sites

Distribution

Worldwide distribution: USA (nationwide) and countries of: England, United Kingdom and United Arab Emirates.

Date initiated

2012-03-15

Date posted

2012-09-07

Date terminated

2012-10-02

Location

Tucson, AZ