Z-2216-2012Class III

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

Name: Z-2216-2012 Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Creator: Sunquest Information Systems, Inc.
Published: 2011-04-28
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2011-04-28 / Terminated / root cause: software

FDA source

Sunquest Information Systems, Inc. began a recall of Sunquest Laboratory SMART & Sunquest Laboratory SMART Select on 2011-04-28. FDA classified it as Class III and gives the reason as "In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of...". 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-2216-2012
Classification: Class III
Status: Terminated
Initiated: 2011-04-28
Posted: 2012-08-16
Terminated: 2012-09-04
Recalling firm: CliniSys, Inc
Product: Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or
Root cause tag: software
FDA root cause: Software design
Action: Sunquest sent an Urgent Product Safety Notice dated April 27, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. For the 103 sites that still have this issue Sunquest distribute a new maintenance release. Customers were instructed to use LabAccess Results Workstation (LARS) instead of Online Entry when entering results for instrument method codes that are defined to use replicate tests that are typically ordered on the same accession. Customers were also instructed to share this notification with appropriate laboratory personnel. Customers were questions should call 520-570-2000. For questions regarding this recall call 520-570-2252.
Quantity in commerce: 103 sites
Distribution: Nationwide Distribution
Product codes and lots: Version 6.3.0 and Later

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2216-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2216-2012	Class III	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-16

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)