Nichols IRMA Intact PTH Assay, catalog No. 40-2171
FDA device recall Z-0809-05 · posted 2005-05-10 · Terminated
Recall details
- Recalling firm
- Nichols Institute Diagnostics
- Reason for recall
- Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CEW
- Quantity affected
- Not divulged
- Distribution
- Nationwide, Canada, Greece, Italy, Sweden, Austria, Balgium, Korea, Spain, Grea Britian, Taiwan, Finland, Denmark, New Zealand, Israel
- Date initiated
- 2005-03-25
- 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 |
|---|---|---|
| ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY (K861797) | Nichols Institute Diagnostics | 1986-07-22 |