Diagnostic Products Corp. IMMULITE 2000 Total Testosterone Kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMMULITE 2000 Total Testosterone Kit
Brand
Diagnostic Products Corp.
Lot Codes / Batch Numbers
CATALOG & LOT NUMBERS: L2KTW 2 Lot 126 (200-test kit) L2KTW 6 Lot 126 (600-test kit)
Products Sold
CATALOG & LOT NUMBERS: L2KTW 2 Lot 126 (200-test kit) L2KTW 6 Lot 126 (600-test kit)
Diagnostic Products Corp. is recalling IMMULITE 2000 Total Testosterone Kit due to 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 Estradio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026