Z-0528-06

IMMULITE 2000 Total Testosterone Kit

Name: Z-0528-06 IMMULITE 2000 Total Testosterone Kit
Creator: Diagnostic Products Corp.
Published: 2006-01-03
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2006-01-03 / Terminated / root cause: manufacturing process

FDA source

Diagnostic Products Corp. began a recall of IMMULITE 2000 Total Testosterone Kit on 2006-01-03. The reason FDA records is "The reagent for this kit lot (L2KTW 2,6 126) was manufactured with a raw material that can carryover and interfere with DPC Kit IMMULITE 2000 Estradiol (L2KE2) causing a false elevation in the observed estradiol...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0528-06
Status: Terminated
Initiated: 2006-01-03
Posted: 2006-02-16
Terminated: 2006-08-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 2000 Total Testosterone Kit
Product code: CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Reason for recall: The reagent for this kit lot (L2KTW 2,6 126) was manufactured with a raw material that can carryover and interfere with DPC Kit IMMULITE 2000 Estradiol (L2KE2) causing a false elevation in the observed estradiol concentration.
Root cause tag: manufacturing process
FDA root cause: Other
Action: For domestic customers - the recall is extended to the domestic end user-level. Domestic customers were notified via telephone using a Phone Script (attached in Attachment 5), starting on January 5,2005. Each customer receives a fax-back form and a Technical Bulletin directly after this phone contact. For foreign consignees - the recall is extended to foreign distributors. It is the distributor''s responsibility to extend the recall action to their direct customers. Foreign consignees were notified via e-mail and/or FAX,starting on January 3, 2005.
Quantity in commerce: 710
Distribution: Nationwide and Worldwide in Pakistan, Italy, Cyprus, Turkey, Switzerland, Chile, South Africa, Greece, Mexica, Canada, Thialand, Germany, India, United Arab Emirates, Hungary, Israel, Portugal, Taiwan, Austria, Saudi Arabia, Malaysia, Hong Kong, India, Colombia, Argentina, Australia, Costa Rica, Czech Republic, Spain, France, Panama, Brazil, Netherlands, Poland, Sweden, United Kingdom, & El Salvadon.
Product codes and lots: CATALOG & LOT NUMBERS: L2KTW 2 Lot 126 (200-test kit) L2KTW 6 Lot 126 (600-test kit)

Product code CDZ

K032881Class IImmulite/immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. / cleared 2003-10-10

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)