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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 Recall
PROTrac II Tacrolimus ELISA kit
see related information
Date Posted April 20, 2015
Recall Status1 Open
Recall Number Z-1464-2015
Recall Event ID 70773
Premarket Approval
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, Minnesota 55082-7536
Manufacturer Reason
for Recall
Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MLM and Applicant = DIASORIN, INC.
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