Recall Z-0724-04 ยท CEW Radioimmunoassay, Parathyroid Hormone
Diagnostic Products Corp
IMMULITE 2000 Intact PTH kit
| Date | Jul 20, 2004 (initiated Feb 23, 2004) |
| Status | Terminated |
| Reason | High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 Medical Center, West Haven, CT Walter Reed Army Medical Center, Washington DC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013566 | IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 Diagnostic Products Corp., Nov 20, 2001 |