Z-0972-04

Immulite 1000 CEA Catalog No. LKCE1

Name: Z-0972-04 Immulite 1000 CEA Catalog No. LKCE1
Creator: Diagnostic Products Corp
Published: 2004-05-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-05-03 / Terminated

FDA source

Diagnostic Products Corp began a recall of Immulite 1000 CEA Catalog No. LKCE1 on 2004-05-03. The reason FDA records is "Instabililty". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0972-04
Status: Terminated
Initiated: 2004-05-03
Posted: 2004-07-20
Terminated: 2004-07-01
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Immulite 1000 CEA Catalog No. LKCE1
Product code: DHX System, Test, Carcinoembryonic Antigen
Reason for recall: Instabililty
FDA root cause: Other
Action: Notice was made via email or telephone. Users are to discard kits.
Quantity in commerce: 884
Product codes and lots: Lots 5 157 and 5 157L

Product code DHX

K970877Class IIImmulite CeaDiagnostic Products Corp. / cleared 1997-09-22

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)