Recall Z-1118-04 ยท MRG System, Test, Vitamin D
Nichols Institute Diagnostics
Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.
| Date | Feb 24, 2005 (initiated Jun 30, 2004) |
| Status | Terminated |
| Reason | Lower than expected results are obtained. |
| Root cause | Other |
| Action | 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. |
| Quantity | Not Applicable. |
| Distribution | Nationwide. Canada, Australia, Greece, Denmark, Portugal, Sweden, Brazil, Italy, japan, Spain, Germany, France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012367 | VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D Nichols Institute Diagnostics, Oct 9, 2001 |