Recall Z-0809-05 ยท CEW Radioimmunoassay, Parathyroid Hormone
Nichols Institute Diagnostics
Nichols IRMA Intact PTH Assay, catalog No. 40-2171
| Date | May 10, 2005 (initiated Mar 25, 2005) |
| Status | Terminated |
| Reason | Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling. |
| Root cause | Other |
| Action | Firm sent customer notifications to firms on March 9 and 11, 2005 which were deemed not appropriate upon review by the FDA, firm agreed to resend notices approved by FDA on March 25, 2005 which requested that customers cease using the lots and destroy inventory for credit. |
| Quantity | Not divulged |
| Distribution | Nationwide, Canada, Greece, Italy, Sweden, Austria, Balgium, Korea, Spain, Grea Britian, Taiwan, Finland, Denmark, New Zealand, Israel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K861797 | ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY Nichols Institute Diagnostics, Jul 22, 1986 |