Sunquest Laboratory, version 7.0 not available

FDA device recall Z-0250-2013 · posted 2012-11-06 · Terminated

Recall details

Recalling firm

Sunquest Information Systems, Inc.

Reason for recall

Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.

Action taken

Sunquest Information Systems, Inc. sent a recall letter dated November 3, 2011, to all affected customers. Customers were informed of the problem identified and the actions to be taken. Customers were informed that a change request CR11-00174907 has been created to address this issue. This will be available as part of Sunquest Laboratory version 7.0.1. To request the software correction, customers were instructed to create a Case via the Client Support webpage at www.sunquestinfo.com/supportweb. Then choose a new case, and finally select work queue and select software request. Customers with questions were instructed to call (877) 239-6337 for US and Canadian sites and at +44 (0) 161 335 0562 for international sites. For questions regarding this recall call 520-570-2252.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

14 sites

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Ireland

Date initiated

2011-11-03

Date posted

2012-11-06

Date terminated

2012-11-06

Location

Tucson, AZ