IMMULITE 2000 Intact PTH kit
FDA device recall Z-0724-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Diagnostic Products Corp
- Reason for recall
- High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.
- Action taken
- Recall was by letter mailed / faxed on February 23, 2004. Users are instructed to remove EDTA plasma samples for consideration for testing and correct instructions in the package insert.
- Root cause
- Other
- Status
- Terminated
- Product code
- CEW
- Quantity affected
- 2416 kits
- Distribution
- North America, Central America, South America, Europe, Asia, South Africa, Middle East. Domestic includes: VA Hospital, St. Louis MO VA Medical Center, Denver, CO VA Medical Center, Richmond, VA VA Me
- Date initiated
- 2004-02-23
- Date posted
- 2004-07-20
- Date terminated
- 2004-12-02
- 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 INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 (K013566) | Diagnostic Products Corp. | 2001-11-20 |