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U.S. Department of Health and Human Services

Class 3 Device Recall DiaSorin TRYPSIK

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  Class 3 Device Recall DiaSorin TRYPSIK see related information
Date Initiated by Firm February 15, 2007
Date Posted April 14, 2007
Recall Status1 Terminated 3 on July 15, 2007
Recall Number Z-0748-2007
Recall Event ID 37606
510(K)Number K791202  
Product Classification Trypsin-like immunoreactivity assay - Product Code JNO
Product DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples)
Code Information Part # P2573, Lot 118532
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
Manufacturer Reason
for Recall		 Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)
FDA Determined
Cause 2		 Other
Action The consignees & distributors were notified by letter on 2/15/07 . The Distributors are instructed to forward the notification to the customers who have received the affected products. A response form will be requested from the customers.
Quantity in Commerce 100 kits
Distribution Worldwide Distribution --- USA including states of UT, CO, IN, NC, CA, FL and countries of Canada, Spain, Germany, Belgium & Italy.
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 = JNO and Original Applicant = CIS RADIOPHARMACEUTICALS, INC.
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