Z-0214-2009

Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. The system is...

Name: Z-0214-2009 Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. The system is...
Creator: Sunquest Information Systems, Inc.
Published: 2008-08-01
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2008-08-01 / Terminated / root cause: software

FDA source

Sunquest Information Systems, Inc. began a recall of Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. The system is marketed as an automated solution for managing... on 2008-08-01. The reason FDA records is "While performing in-house testing for the Sunquest Laboratory System and under certain conditions, there have been instances in which an error that occurred at the database level or originated in the operating system...". 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-0214-2009
Status: Terminated
Initiated: 2008-08-01
Posted: 2008-11-12
Terminated: 2011-11-28
Recalling firm: CliniSys, Inc
Product: Sunquest Laboratory System. Software Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3. The system is marketed as an automated solution for managing laboratory processes including: 1) Patient registration, 2) Order entry and order modification, 3) Specimen collection, verification, suitability, and distribution, 4) Quality assurance checking, 5) Workload recording, 6) Billing charge capture, 7) Standards and controls recording, 8) Test order result inquiry and reporting, 9) Organism susceptibility and epidemiology records, 10) Microbiology culture direct examination and observation recording, 11) Outreach clients, specimens, and results, 12) Client-specific reporting capabilities, 13) Inbound client service request tracking, and 14) Historical data.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: While performing in-house testing for the Sunquest Laboratory System and under certain conditions, there have been instances in which an error that occurred at the database level or originated in the operating system (Cache)was not communicated or displayed in the Graphic User Interface (GUI) application so the activity continued. While this error was registered in the error log in the System U
Root cause tag: software
FDA root cause: Software design
Action: A notice (PSN-08-07) was issued to all customers on 08/01/2008 via e-mail. The notice advises customers of the problem and actions Sunquest Information Systems has taken to eliminate the Problem. Sunquest Client Support will contact their facility to schedule correcting the error trap setting. The notice also provides temporary procedural instructions to include monitoring error log using System Utilities (Function UTL) and suboption 2, System Error/Message Inquiry. Contact Client Support at 520-570-2252 for questions or additional information.
Quantity in commerce: 139
Distribution: Worldwide Distribution including USA and countries of Canada, Denmark, Saudi Arabia and United Arab Emirates.
Product codes and lots: Version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3.

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)