Z-0994-05

IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by...

Name: Z-0994-05 IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by...
Creator: DPC Cirrus
Published: 2005-04-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-04-22 / Terminated

FDA source

DPC Cirrus began a recall of IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836 on 2005-04-22. The reason FDA records is "The Transport Chain is used to move a Reaction Tube within the Immulite 2000. It goes on to state the error condition that occurs due to a false trip of the home sensor". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0994-05
Status: Terminated
Initiated: 2005-04-22
Posted: 2005-07-16
Terminated: 2006-06-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The Transport Chain is used to move a Reaction Tube within the Immulite 2000. It goes on to state the error condition that occurs due to a false trip of the home sensor.
FDA root cause: Other
Action: The firm became aware of the problem on 4/19 and conducted tests on 4/22/05. A service alert for field service engineers and Immulite 2000 distributors was prepared on 4/22/05.
Quantity in commerce: There are 941 units in the United States and 3014 units in the international market.
Distribution: worldwide
Product codes and lots: All analyzers; all serial numbers.

Product code JJE

K970227Class IImmulite 2000 Automated Immunoassay AnalyzerDpc Cirrus / cleared 1997-04-08

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)