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
|
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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.
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PMA Database |
PMAs with Product Code = MLM and Original Applicant = DIASORIN, INC.
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