Z-0238-04

Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results

Name: Z-0238-04 Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results
Creator: Misys Healthcare Systems
Published: 2003-07-21
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2003-07-21 / Terminated

FDA source

Misys Healthcare Systems began a recall of Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results on 2003-07-21. The reason FDA records is "Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0238-04
Status: Terminated
Initiated: 2003-07-21
Posted: 2004-07-20
Terminated: 2004-11-15
Recalling firm: CliniSys, Inc
Product: Misys Laboratory System, versions 5.3 build 63 through 5.3.2 and LabAccess Results.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Incorrect demographics display which can result in incorrect information being used in diagnosis or treatment of patients.
FDA root cause: Other
Action: A temporary procedural workaround was communicated by fax to customers in Product Safety Notice PSN-03-L33 on July 21, 2003. Asecond Notice (L33A) was sent to customers to futher facilitate the recall.
Quantity in commerce: 125
Distribution: Nationwide, Canada, Saudi Arabia, United Kingdom.
Product codes and lots: Version 5.3 build 63 thru 6.3.2 and LabAccess Results.

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)