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.
Rapid ffn cassettes were manufactured with material (a137 ascites) from a new supplier (sdix). the products were distributed to customers before fda approved the change to use the material from sdix.
조치
Hologic initiated the recall on Wednesday, November 29, 2017. The method of notification was via overnight FedEx.