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U.S. Department of Health and Human Services

Class 3 Device Recall DiaSorin Liaison 25 OH vitamin D Assay

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  Class 3 Device Recall DiaSorin Liaison 25 OH vitamin D Assay see related information
Date Initiated by Firm February 14, 2005
Date Posted March 18, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall Number Z-0637-05
Recall Event ID 31167
510(K)Number K032844  
Product Classification System, Test, Vitamin D - Product Code MRG
Product LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E.
Code Information catalog no. 310900, lot 114439E
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact DiaSorin Technical Service
800-328-1482
Manufacturer Reason
for Recall		 Results of an internal inspection show Lot 114439E to have calibrator 1 and Calibrator 2 switched in their position in the integral. This results in an inability to calculate a curve, due to the reversal of calibrator values.
FDA Determined
Cause 2		 Other
Action DiaSorin Customer Notification dated 02/14/05 was sent to customers instructing them to destroy all kits from the affected lot number. Customers were also asked to complete and return a form indicating how many kits were destroyed.
Quantity in Commerce 131
Distribution MI, NJ, Germany, Spain and Belgium
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MRG and Original Applicant = DIASORIN, INC.
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