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U.S. Department of Health and Human Services

Class 3 Device Recall Liaison 25OH Vitamin D Kit

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  Class 3 Device Recall Liaison 25OH Vitamin D Kit 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-0638-05
Recall Event ID 31228
510(K)Number K032844  
Product Classification System, Test, Vitamin D - Product Code MRG
Product Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668
Code Information manufacturer part # 310900, Lot #114668
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
Manufacturer Reason
for Recall		 An internal inspection indicates that Calibrator 2 and Conjugate are switched in their positions in the integral. This will result in Calibrator 1 RLU's similar to that of background RLU, and Calibrator 2 RLU's near expected range. A curve can not be calculated from this data.
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 31 kits
Distribution MA, Spain, Germany & 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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