Z-0250-2013Class II

Sunquest Laboratory, version 7.0 not available

Name: Z-0250-2013 Sunquest Laboratory, version 7.0 not available
Creator: Sunquest Information Systems, Inc.
Published: 2011-11-03
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2011-11-03 / Terminated / root cause: software

FDA source

Sunquest Information Systems, Inc. began a recall of Sunquest Laboratory, version 7.0 not available on 2011-11-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0250-2013
Classification: Class II
Status: Terminated
Initiated: 2011-11-03
Posted: 2012-11-06
Terminated: 2012-11-06
Recalling firm: CliniSys, Inc
Product: Sunquest Laboratory, version 7.0 not available
Product code: JQP Calculator/Data Processing Module, For Clinical Use
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.
Root cause tag: software
FDA 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 in commerce: 14 sites
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Ireland
Product codes and lots: not available

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0250-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0250-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-14	2012-11-06

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)