Z-0724-04

IMMULITE 2000 Intact PTH kit

Name: Z-0724-04 IMMULITE 2000 Intact PTH kit
Creator: Diagnostic Products Corp
Published: 2004-02-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2004-02-23 / Terminated

FDA source

Diagnostic Products Corp began a recall of IMMULITE 2000 Intact PTH kit on 2004-02-23. The reason FDA records is "High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0724-04
Status: Terminated
Initiated: 2004-02-23
Posted: 2004-07-20
Terminated: 2004-12-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 2000 Intact PTH kit
Product code: CEW Radioimmunoassay, Parathyroid Hormone
Reason for recall: High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.
FDA root cause: Other
Action: Recall was by letter mailed / faxed on February 23, 2004. Users are instructed to remove EDTA plasma samples for consideration for testing and correct instructions in the package insert.
Quantity in commerce: 2416 kits
Distribution: North America, Central America, South America, Europe, Asia, South Africa, Middle East. Domestic includes: VA Hospital, St. Louis MO VA Medical Center, Denver, CO VA Medical Center, Richmond, VA VA Medical Center, West Haven, CT Walter Reed Army Medical Center, Washington DC
Product codes and lots: Kit lots L2KPP 117 (exp date Aug 31 2004) and 118 (exp date Oct 31 2004)

Product code CEW

K013566Class IIImmulite Intact Pth, Immulite 2000 Intact Pth, Models Lkpp1 (100 Tests), Lkpp5 (500 Tests), L2kpp2 (200 Tests), L2kpp6Diagnostic Products Corp. / cleared 2001-11-20

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)