Recall Z-0707-2007 ยท MRG System, Test, Vitamin D
Diasorin Inc.
1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma-DiaSorin, Stillwater, Minnesota 55082-0285, USA
| Date | Apr 3, 2007 (initiated Jun 5, 2006) |
| Status | Terminated |
| Reason | Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the defined range, the run is considered invalid) |
| Root cause | Other |
| Action | Product recalled by letter dated 6/01/2006 |
| Quantity | 715 |
| Distribution | Worldwide Distribution-USA including states of UT, CO, IL, NY, NV, MI, NC, MN, VA, GA, CA, KS, VT, CT and IN, and Countries of Canada, Sweden, Germany, Belgium, Italy, France, Norway, Australia, South Korea, Taiwan, Israel, New Foundland, India, China, Brazil, Austria, Saudi Arabia, and Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014030 | 1,25-DIHYDROXYVITAMIN D125I RIA DiaSorin, Inc., Mar 26, 2002 |