IMMULITE 2000 Total Testosterone Kit
FDA device recall Z-0528-06 · posted 2006-02-16 · Terminated
Recall details
- Recalling firm
- Diagnostic Products Corp.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CDZ
- Quantity affected
- 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
- Date initiated
- 2006-01-03
- Date posted
- 2006-02-16
- Date terminated
- 2006-08-30
- Location
- Los Angeles, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (K032881) | Diagnostic Products Corp. | 2003-10-10 |