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U.S. Department of Health and Human Services

Class 2 Device Recall PROTrac II Tacrolimus ELISA kit

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  Class 2 Device Recall PROTrac II Tacrolimus ELISA kit see related information
Date Initiated by Firm March 16, 2015
Date Posted April 20, 2015
Recall Status1 Terminated 3 on September 15, 2015
Recall Number Z-1464-2015
Recall Event ID 70773
PMA Number P970025 
Product Classification Enzyme immunoassay, tracrolimus - Product Code MLM
Product DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN.
Product Usage:
The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy.
Code Information 131716, 131716A, 131716B, 131716C, 131716D, 131716E,  131717.
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact
651-439-9710
Manufacturer Reason
for Recall		 Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
FDA Determined
Cause 2		 Under Investigation by firm
Action DiaSorin sent a Customer Notification Letter" to affected customers. The letter identifed the affected product, problem and actions to be taken. Customers were asked to complete and return the confirmation form to the manufacturer. For questions contact DiaSorin Inc. Product Support at 1-800-328-1482.
Quantity in Commerce 451 kits
Distribution Worldwide Distribution - US in the state of CA and the countries of: CHINA, BELGIUM, ARGENTINA, and INDIA.
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.
PMA Database PMAs with Product Code = MLM and Original Applicant = DIASORIN, INC.
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