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.
Some units exhibit weak false-positive reactions with some negative patient serum.
조치
The recalling firm issued a letter dated 2/14/06 to their only customer requesting the product be destroyed.
The distributor was audited by FDA to assure subrecall