IMMULITE 2000 Total Testosterone Kit
- Company
- Diagnostic Products Corp.
- Recall Initiated
- January 3, 2006
- Posted
- February 16, 2006
- Terminated
- August 30, 2006
- Recall Number
- Z-0528-06
- Quantity
- 710
- Firm Location
- Los Angeles, CA
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.
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.
Lot / Code Info
CATALOG & LOT NUMBERS: L2KTW 2 Lot 126 (200-test kit) L2KTW 6 Lot 126 (600-test kit)
Root Cause
Other
Action Taken
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.