Z-0646-03

Misys Laboratory System Version 5.3

Name: Z-0646-03 Misys Laboratory System Version 5.3
Creator: Misys Healthcare Systems
Published: 2003-02-06
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2003-02-06 / Terminated

FDA source

Misys Healthcare Systems began a recall of Misys Laboratory System Version 5.3 on 2003-02-06. The reason FDA records is "Two customers report that the organism identified on the patient's lab file do not match the reported susceptibility battery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0646-03
Status: Terminated
Initiated: 2003-02-06
Posted: 2003-03-13
Terminated: 2004-05-07
Recalling firm: CliniSys, Inc
Product: Misys Laboratory System Version 5.3
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Two customers report that the organism identified on the patient's lab file do not match the reported susceptibility battery.
FDA root cause: Other
Action: Firm notified customers by fax on 2/6/2003. This included a workaround procedure. A correcting software package will be created and announced at a later date. Estimated completion date is May 1, 2003
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)