Class 3 Device Recall DiaSorin TRYPSIK

• Date Initiated by Firm: February 15, 2007
• Date Posted: April 14, 2007
• Recall Status: Terminated 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
• FEI Number: 2182595
• 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: 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