Recall Z-1044-05 ยท CKG Radioimmunoassay, Acth
Nichols Institute Diagnostics
Nichols Advantage ACTH Test System, catalog number 62-7004.
| Date | Jul 28, 2005 (initiated Apr 22, 2005) |
| Status | Terminated |
| Reason | Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay. |
| Root cause | Other |
| Action | Firm send letters to Lab Directors on April 22 and 29th, 2005 requesting destruction of product for credit. |
| Quantity | 1203 |
| Distribution | Nationwide and Hungary, Poland, Australia, Canada, Germany, Greece, Italy, Spain, Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962601 | NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE Nichols Institute Diagnostics, Dec 24, 1996 |