Z-0938-05

Misys Laboratory with Lab Access Results application for versions 5.3 and later

Name: Z-0938-05 Misys Laboratory with Lab Access Results application for versions 5.3 and later
Creator: Misys Healthcare Systems
Published: 2005-05-13
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2005-05-13 / Terminated / root cause: software

FDA source

Misys Healthcare Systems began a recall of Misys Laboratory with Lab Access Results application for versions 5.3 and later on 2005-05-13. The reason FDA records is "Software anomaly may rarely allow modification of previously reported specimen results". 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-0938-05
Status: Terminated
Initiated: 2005-05-13
Posted: 2005-06-28
Terminated: 2006-02-10
Recalling firm: CliniSys, Inc
Product: Misys Laboratory with Lab Access Results application for versions 5.3 and later.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Software anomaly may rarely allow modification of previously reported specimen results.
Root cause tag: software
FDA root cause: Other
Action: Product Safety Notice PSN-05-01 was sent by fax on May 13, 2005 and includes a procedural work-around to avoid the defect until the firm is able to provide a software patch.
Quantity in commerce: 258
Distribution: Nationwide and United Kingdom, Ireland, Denmark, Canada, Saudi Arabia, United Arab Emirates
Product codes and lots: Versions 5.3 and later.

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)