Recall Z-0056-06 ยท CEW Radioimmunoassay, Parathyroid Hormone
Nichols Institute Diagnostics
Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045.
| Date | Oct 15, 2005 (initiated Apr 14, 2005) |
| Status | Terminated |
| Reason | Controls were out of specification range. |
| Root cause | Other |
| Action | Recall letter and response form was sent on April 14, 2005 to all domestic and foreign consignees. |
| Quantity | 323 |
| Distribution | Nationwide, Japan, Spain, Germany and Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.