Z-2229-2012Class III

Sunquest Laboratory SMART & Sunquest Laboratory SMART Select

Name: Z-2229-2012 Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Creator: Sunquest Information Systems, Inc.
Published: 2011-08-12
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2011-08-12 / Terminated / root cause: manufacturing process

FDA source

Sunquest Information Systems, Inc. began a recall of Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use on 2011-08-12. FDA classified it as Class III and gives the reason as "In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2229-2012
Classification: Class III
Status: Terminated
Initiated: 2011-08-12
Posted: 2012-08-21
Terminated: 2012-09-04
Recalling firm: CliniSys, Inc
Product: Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Sunquest sent an Urgent - Product Safety Notice letter dated August 12, 2011 to all affected customers. The letter identified the affected product, summary of the problem, actions to eliminate the problem and actions to be taken by clients. Sunquest will distribute a new maintenance release. Client Support can be reached at 1-877-239-0337 for U.S and Canadian sites and at +44 (0) 101-335-0562 for international sites.
Quantity in commerce: 47 sites
Distribution: US Nationwide Distribution
Product codes and lots: Version 6.4.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2229-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2229-2012	Class III	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-20

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)