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
in vitro diagnostic - Product Code MID
원인
Customers were not following the labeled assay procedure. this was due to a letter issued to them in 2004 from phadia gmbh, which indicated that customers could omit the pre-wash step. the omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results.
조치
On 8/2/2012 an URGENT PRODUCT CORRECTION INFORMATION FOR PHADIA VARELISA CARDIOLIPIN IGM, Article Number 15696 letter was sent to all consignees the received the Direction for Use modification letter in 2004.