Skip to the content

FDA Medical Device Recalls (openFDA)

Sunquest Information Systems, Inc.: Sunquest Laboratory, version 7.0 not available

Recall number
Z-0250-2013
Recalling firm
Sunquest Information Systems, Inc.
Product
Sunquest Laboratory, version 7.0 not available
Status
Terminated
Initiated
2011-11-03
Posted
2012-11-06
Terminated
2012-11-06
Reason
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.
Root cause
Software design
Action
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.
Quantity
14 sites
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Ireland
Lot, serial or model codes
not available
510(k) numbers
not on file
PMA numbers
not on file
Product code
JQP
Firm FEI
1000306472
Firm city
Tucson
Firm state
AZ
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Search this register