Z-0647-03

Misys Laboratory, version 5.3 with Reference Laboratory Interface

Name: Z-0647-03 Misys Laboratory, version 5.3 with Reference Laboratory Interface
Creator: Sunquest Information Systems
Published: 2002-10-18
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2002-10-18 / Terminated / root cause: software

FDA source

Sunquest Information Systems began a recall of Misys Laboratory, version 5.3 with Reference Laboratory Interface on 2002-10-18. The reason FDA records is "Software anomaly, incorrect coding. Some comments were not transfered when coming from the Reference Laboratory Interface". 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-0647-03
Status: Terminated
Initiated: 2002-10-18
Posted: 2003-03-13
Terminated: 2004-12-03
Recalling firm: CliniSys, Inc
Product: Misys Laboratory, version 5.3 with Reference Laboratory Interface
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Software anomaly, incorrect coding. Some comments were not transfered when coming from the Reference Laboratory Interface.
Root cause tag: software
FDA root cause: Other
Action: A product workaround was communicated to the two affected sites by facsimile on October 18, 2002. The recall is complete.
Quantity in commerce: 2
Distribution: States of WI, and IL.
Product codes and lots: Version 5.3 with Reference Laboratory Interface

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)