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
Instrumentation for clinical multiplex test systems - Product Code NSU
원인
An incorrect incubator was installed on one panther system which potentially led to incorrect aptima combo 2(r) assay (ac2) results.
조치
The customer was notifed of the potential incorrect results via a phone call on September 15, 2017.
A customer letter was sent on September 18, 2017.
¿ The notification letter requests the customer to re-test any negative Aptima Combo 2 assay results tested between July 13, 2017 Aug 30, 2017.