Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045.
FDA device recall Z-0056-06 · posted 2005-10-15 · Terminated
Recall details
- Recalling firm
- Nichols Institute Diagnostics
- Reason for recall
- Controls were out of specification range.
- Action taken
- Recall letter and response form was sent on April 14, 2005 to all domestic and foreign consignees.
- Root cause
- Other
- Status
- Terminated
- Product code
- CEW
- Quantity affected
- 323
- Distribution
- Nationwide, Japan, Spain, Germany and Sweden
- Date initiated
- 2005-04-14
- Date posted
- 2005-10-15
- 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.