Z-0678-03

Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI...

Name: Z-0678-03 Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI...
Creator: Misys Healthcare Systems
Published: 2003-01-17
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2003-01-17 / Terminated / root cause: software

FDA source

Misys Healthcare Systems began a recall of Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3 on 2003-01-17. The reason FDA records is "Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol". 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-0678-03
Status: Terminated
Initiated: 2003-01-17
Posted: 2003-03-26
Terminated: 2004-05-07
Recalling firm: CliniSys, Inc
Product: Misys Laboratory, Calculator/Data processing Module for Clinical Use (21 CFR 862.2100) Misys Laboratory GUI Version 5.3
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol.
Root cause tag: software
FDA root cause: Other
Action: Firm sent notice by fax on 1/17/2003. The notice includes information about an effective workaround and indicates that the firm will announce the availability of a software correction when it''s ready.
Quantity in commerce: 520
Distribution: Nationwide and to United Kingdom, Ireland, Canada, Denmark, 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)