Z-0807-03

Misys Laboratory System version 5.3

Name: Z-0807-03 Misys Laboratory System version 5.3
Creator: Misys Healthcare Systems
Published: 2003-04-01
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2003-04-01 / Terminated / root cause: software

FDA source

Misys Healthcare Systems began a recall of Misys Laboratory System version 5.3 on 2003-04-01. The reason FDA records is "Software anomally, One client reported patient tests and results are deleted when duplicate orders are placed". 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-0807-03
Status: Terminated
Initiated: 2003-04-01
Posted: 2003-05-09
Terminated: 2004-04-21
Recalling firm: CliniSys, Inc
Product: Misys Laboratory System version 5.3
Reason for recall: Software anomally, One client reported patient tests and results are deleted when duplicate orders are placed.
Root cause tag: software
FDA root cause: Other
Action: Notice was sent by fax on 4/1/2003 under Product Safety Notice, PSN-03-L17. A code modification is yet to be released. Customers have been provided with a temporary workaround procedure.
Quantity in commerce: 3
Distribution: States of MI, OH, NY.
Product codes and lots: Version 5.3 only.

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)