Z-1138-03

Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software

Name: Z-1138-03 Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software
Creator: DPC Cirrus
Published: 2003-06-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2003-06-13 / Terminated / root cause: software

FDA source

DPC Cirrus began a recall of Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software on 2003-06-13. The reason FDA records is "Version 2.6 software was released however it will not properly handle adjustment slopes". 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-1138-03
Status: Terminated
Initiated: 2003-06-13
Posted: 2003-08-20
Terminated: 2004-11-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Version 2.6 software was released however it will not properly handle adjustment slopes.
Root cause tag: software
FDA root cause: Other
Action: Recall Technical Bulletins were sent out on 6/13/2003 to all Immulite 2000 users instructing them to not install the provided version 2.6 software.
Quantity in commerce: 434 upgrades
Distribution: Software was distributed to Immulite 2000 users throughout the nation. These units are found in hospitals and clinics. Software was also distributed to the firm''s service representatives.
Product codes and lots: All units.

Product code JJE

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)