1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or...
Diasorin Inc. began a recall of 1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma-DiaSorin, Stillwater, Minnesota... on . The reason FDA records is "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...". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0707-2007
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Diasorin Inc.
- Product
- 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
- Product code
- MRG System, Test, Vitamin D
- Reason for recall
- 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)
- FDA root cause
- Other
- Action
- Product recalled by letter dated 6/01/2006
- Quantity in commerce
- 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
- Product codes and lots
- Catalog #65100E. Kit Lot #''s 117139, 117140, 1117141
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
