Z-0251-2013Class II

Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later

Name: Z-0251-2013 Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later
Creator: Sunquest Information Systems, Inc.
Published: 2009-11-19
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2009-11-19 / Terminated / root cause: manufacturing process

FDA source

Sunquest Information Systems, Inc. began a recall of Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later on 2009-11-19. FDA classified it as Class II and gives the reason as "The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately". 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-0251-2013
Classification: Class II
Status: Terminated
Initiated: 2009-11-19
Posted: 2012-11-06
Terminated: 2012-11-06
Recalling firm: CliniSys, Inc
Product: Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Sunquest sent an "URGENT-PRODUCT SAFETY NOTICE: PSN-09-06" letter dated November 19, 2009 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were informed that Sunquest Application Interfacing would be contacting their facility for scheduling to correct the issue.
Quantity in commerce: 9 units
Distribution: Nationwide Distribution.
Product codes and lots: v3.0.0_07222004 and later

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0251-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0251-2013	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)