Z-0263-05

Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system

Name: Z-0263-05 Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system
Creator: DPC Cirrus
Published: 2004-10-29
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-10-29 / Terminated

FDA source

DPC Cirrus began a recall of Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system on 2004-10-29. The reason FDA records is "Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0263-05
Status: Terminated
Initiated: 2004-10-29
Posted: 2004-11-30
Terminated: 2005-01-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.
Product code: DHA System, Test, Human Chorionic Gonadotropin
Reason for recall: Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'.
FDA root cause: Other
Action: The firm faxed the technical bulletin notification to each domestic customer on 10/22/2004. International customers were e-mailed and faxed on the same day.
Quantity in commerce: 17 UNITS
Distribution: The firm distributed the IMMULITE 2500 nationwide and internationally. The international customers are located in Portugal, Turkey, Australia, Switzerland, Czech Rep.,Germany, Spain, France, Netherlands, Sweden, Denmark, United Kingdom, and Italy.
Product codes and lots: Serial Number: B0071; B0095; B0055; B0060; B0124; B0131; B0097; B0106; B0064; B0087; B0073; B0113; B0121; B0135; B0122; B0123; B0102.

Product code DHA

K033234Class IIImmulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. / cleared 2003-12-12

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)