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U.S. Department of Health and Human Services

Class 3 Device Recall DiaSorin programming software

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  Class 3 Device Recall DiaSorin programming software see related information
Date Initiated by Firm April 12, 2004
Date Posted April 13, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall Number Z-0702-05
Recall Event ID 30929
PMA Number P970025 
Product Classification Enzyme Immunoassay, Tracrolimus - Product Code MLM
Product Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit
Code Information version 12
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information Contact DiaSorin Technical Services
800-328-1482
Manufacturer Reason
for Recall		 The software program written for use in the automated microtiter plate reader (Bio-Tek ELx800) for use with the Pro-Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert.
FDA Determined
Cause 2		 Other
Action Customers were sent notification letters and effectiveness check form. recommended users manually veify results using product insert specifications.
Distribution CA, Washington DC, FL, KY & Canada
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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