Z-1015-05

Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303

Name: Z-1015-05 Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
Creator: Diagnostic Products Corp
Published: 2005-05-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-05-26 / Terminated

FDA source

Diagnostic Products Corp began a recall of Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303 on 2005-05-26. The reason FDA records is "Adverse trend in stability, controls biased or out of range". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1015-05
Status: Terminated
Initiated: 2005-05-26
Posted: 2005-07-16
Terminated: 2006-02-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
Product code: DHX System, Test, Carcinoembryonic Antigen
Reason for recall: Adverse trend in stability, controls biased or out of range.
FDA root cause: Other
Action: Recall was initiated by phone using a script, to be followed up with a letter and response form.
Quantity in commerce: 269
Distribution: Nationwide and to Syria, United Kingdom, Puerto Rico, Aruba, Kuwait.
Product codes and lots: Lots 302 and 303

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)