Nichols Advantage ACTH Test System, catalog number 62-7004.
FDA device recall Z-1044-05 · posted 2005-07-28 · Terminated
Recall details
- Recalling firm
- Nichols Institute Diagnostics
- Reason for recall
- Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.
- Action taken
- Firm send letters to Lab Directors on April 22 and 29th, 2005 requesting destruction of product for credit.
- Root cause
- Other
- Status
- Terminated
- Product code
- CKG
- Quantity affected
- 1203
- Distribution
- Nationwide and Hungary, Poland, Australia, Canada, Germany, Greece, Italy, Spain, Sweden
- Date initiated
- 2005-04-22
- Date posted
- 2005-07-28
- Date terminated
- 2012-03-16
- Location
- San Clemente, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE (K962601) | Nichols Institute Diagnostics | 1996-12-24 |