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.
데이터 추가 비고
Instrument, biopsy - Product Code KNW
원인
Incorrect label on the sertera biopsy kit.
조치
Hologic notified customers in the United States through Certified letter on 8/22/16. The letter contains instructions of returning the product, provides contact information, and includes a postage-paid return card for the consignee to complete and return to Hologic. Contact technical support at 508-263-2900 or l-800-442:9892 Press Option 6 ).