Medical Device
Manufacturing
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Z-0707-2007

1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or...

Diasorin Inc. / initiated 2006-06-05 / Terminated

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