Recall Z-0810-05 ยท CEW Radioimmunoassay, Parathyroid Hormone
Nichols Institute Diagnostics
Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040
| Date | May 10, 2005 (initiated Apr 7, 2005) |
| Status | Terminated |
| Reason | Values do not agree with Directional Instructions. |
| Root cause | Other |
| Action | Firm sent separate notices for each lot of product to customers dated March 25, 2005 requesting destruction of remaining product and affirmation of that activity via a response form. Users were also provided detailed listing of performance characteristics related to the deficiencies for thier information and evaluation per thier own lab''s SOP''s. |
| Quantity | 13751 |
| Distribution | Nationwide and to Australia, Canada, Chile, France, Germany, Greece, Italy, japan, Spain, Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033727 | NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY Nichols Institute Diagnostics, Apr 22, 2004 |