IMMULITE 2000 Total Testosterone Kit recallZ-0528-06 · Diagnostic Products Corp. · initiated Jan 3, 2006
Terminated All recalls posted in February 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diagnostic Products Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0528-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 3, 2006
- Posted by the FDA
- Feb 16, 2006
- Recalling firm
- Diagnostic Products Corp.
- Quantity
- 710
- Product code
- CDZ
- FDA submissions
- K032881
- 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 description
IMMULITE 2000 Total Testosterone Kit
Code information (models, lots, serial numbers)
CATALOG & LOT NUMBERS: L2KTW 2 Lot 126 (200-test kit) L2KTW 6 Lot 126 (600-test kit)
Other devices under the same FDA submission
1 device cleared under K032881 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- IMMULITE®/IMMULITE® 1000 Systems TES Total Testosterone 10381156Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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