Recall Z-0528-06 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Diagnostic Products Corp.
IMMULITE 2000 Total Testosterone Kit
| Date | Feb 16, 2006 (initiated Jan 3, 2006) |
| Status | Terminated |
| Reason | 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 | 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 | 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, Cze |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE Diagnostic Products Corp., Oct 10, 2003 |