Z-0939-05

Mysis Laboratory version 6.1

Name: Z-0939-05 Mysis Laboratory version 6.1
Creator: Misys Healthcare Systems
Published: 2005-05-10
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2005-05-10 / Terminated

FDA source

Misys Healthcare Systems began a recall of Mysis Laboratory version 6.1 on 2005-05-10. The reason FDA records is "When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more suceptibilities on the culture will be deleted". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0939-05
Status: Terminated
Initiated: 2005-05-10
Posted: 2005-06-28
Terminated: 2005-08-30
Recalling firm: CliniSys, Inc
Product: Mysis Laboratory version 6.1
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more suceptibilities on the culture will be deleted.
FDA root cause: Other
Action: Firm sent Product Safety Notice PSN 05-02 on May 10, 2005 which also provides a procedural work-around and an invitation to obtain a service pack to correct the software flaw.
Quantity in commerce: 21
Distribution: Nationwide and United Kingdom and Denmark
Product codes and lots: Version 6.1

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)