Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.
FDA device recall Z-1118-04 · posted 2005-02-24 · Terminated
Recall details
- Recalling firm
- Nichols Institute Diagnostics
- Reason for recall
- Lower than expected results are obtained.
- Action taken
- Firm sent Customer Bulletin No 04-09-AD on June 30, 2004. It addresses the issues and advises customers as to alternative actions, including appending results with a caution statement regarding low recovery.
- Root cause
- Other
- Status
- Terminated
- Product code
- MRG
- Quantity affected
- Not Applicable.
- Distribution
- Nationwide. Canada, Australia, Greece, Denmark, Portugal, Sweden, Brazil, Italy, japan, Spain, Germany, France.
- Date initiated
- 2004-06-30
- Date posted
- 2005-02-24
- Date terminated
- 2012-02-10
- 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 |
|---|---|---|
| VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D (K012367) | Nichols Institute Diagnostics | 2001-10-09 |