Z-0495-03

Misys Laboratory, GUI version 5.3

Name: Z-0495-03 Misys Laboratory, GUI version 5.3
Creator: Misys Healthcare Systems
Published: 2002-12-20
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2002-12-20 / Terminated

FDA source

Misys Healthcare Systems began a recall of Misys Laboratory, GUI version 5.3 on 2002-12-20. The reason FDA records is "An incorrect collection date and time may be accepted and filed to the patient file". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0495-03
Status: Terminated
Initiated: 2002-12-20
Posted: 2003-01-30
Terminated: 2004-12-01
Recalling firm: CliniSys, Inc
Product: Misys Laboratory, GUI version 5.3
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: An incorrect collection date and time may be accepted and filed to the patient file.
FDA root cause: Other
Action: The firm's recall notice was sent by fax to all customers on Jan. 3, 2003. It communicated a procedural workaround and the availability of product corrections.
Quantity in commerce: 465
Distribution: Nationwide and to United Kingdom, Ireland, Canada, Denmark, Bermuda, Saudi Arabia, United Arab Emirates.
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)