U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
Customers were sent notification letters and effectiveness check form. recommended users manually veify results using product insert specifications.