Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040
FDA device recall Z-0810-05 · posted 2005-05-10 · Terminated
Recall details
- Recalling firm
- Nichols Institute Diagnostics
- Reason for recall
- Values do not agree with Directional Instructions.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CEW
- Quantity affected
- 13751
- Distribution
- Nationwide and to Australia, Canada, Chile, France, Germany, Greece, Italy, japan, Spain, Sweden
- Date initiated
- 2005-04-07
- Date posted
- 2005-05-10
- 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 BIO-INTACT PTH (1-84) IMMUNOASSAY (K033727) | Nichols Institute Diagnostics | 2004-04-22 |