Z-0088-06

Misys Laboratory version 6.1 - Microbiology Module

Name: Z-0088-06 Misys Laboratory version 6.1 - Microbiology Module
Creator: Misys Healthcare Systems
Published: 2005-09-29
License: https://open.fda.gov/license/

CliniSys, Inc / initiated 2005-09-29 / Terminated / root cause: software

FDA source

Misys Healthcare Systems began a recall of Misys Laboratory version 6.1 - Microbiology Module on 2005-09-29. The reason FDA records is "Customer complaint during testing of module prior to production use. Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000, the system willfile...". 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-0088-06
Status: Terminated
Initiated: 2005-09-29
Posted: 2005-10-22
Terminated: 2006-02-10
Recalling firm: CliniSys, Inc
Product: Misys Laboratory version 6.1 - Microbiology Module
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Customer complaint during testing of module prior to production use. Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000, the system willfile the number 100 instead of number 100,000.
Root cause tag: software
FDA root cause: Other
Action: Telephone calls and emails dated 9/29/05 to all consignees in production. Product Safety Noticed dated 9/29/2005 was faxed to all consignees testing the product.
Quantity in commerce: 67
Distribution: Nationwide and Canada, Denmark, Emirates, Saudi Arabia, United Kingdom
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)