Z-0073-2013Class III

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

Name: Z-0073-2013 Sunquest Laboratory : intended for use by professionals working in a clinical laboratory
Creator: Sunquest Information Systems, Inc.
Published: 2011-11-15
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2011-11-15 / Terminated / root cause: software

FDA source

Sunquest Information Systems, Inc. began a recall of Sunquest Laboratory : intended for use by professionals working in a clinical laboratory on 2011-11-15. FDA classified it as Class III and gives the reason as "Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn...". 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-0073-2013
Classification: Class III
Status: Terminated
Initiated: 2011-11-15
Posted: 2012-10-17
Terminated: 2012-10-19
Recalling firm: CliniSys, Inc
Product: Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.
Root cause tag: software
FDA root cause: Software design
Action: Urgent - Product Safety Notice: PSN-11-06,dated, 15 November 2011, was sent to customers. Costumers should follow instructions in the notification letter. To request the software correction, create a Case via the Client Support webpage at: www.sunquestinfo.com/supportweb. Return receipt acknowledging PSN-11-06 is required . Client Support can be reached at 1-877-239-6337 for U.S. and Canadian sites and at +44 (0) 161 335 0562 for International sites.
Quantity in commerce: 127 sites
Distribution: Nationwide distribution
Product codes and lots: Versions 6.4.0 and later

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0073-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0073-2013	Class III	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-17

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)