Z-0497-03

Reference Library Interface Version 5.3

Name: Z-0497-03 Reference Library Interface Version 5.3
Creator: Sunquest Information Systems
Published: 2002-12-06
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2002-12-06 / Terminated / root cause: software

FDA source

Sunquest Information Systems began a recall of Reference Library Interface Version 5.3 on 2002-12-06. The reason FDA records is "Software system defect resulting in incomplete patient results information". 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-0497-03
Status: Terminated
Initiated: 2002-12-06
Posted: 2003-01-30
Terminated: 2013-02-26
Recalling firm: CliniSys, Inc
Product: Reference Library Interface Version 5.3
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Software system defect resulting in incomplete patient results information.
Root cause tag: software
FDA root cause: Other
Action: Product Safety Notice, PSN-02-L31 will be faxed to all affected customers. The notice provides product users with a description of the problem, an effective workaround, and the estimated release of coding modifications to the software version impacted.
Quantity in commerce: 30
Distribution: Nationwide
Product codes and lots: Version 5.3

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)