Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
데이터 추가 비고
원인
Beckman coulter has received reports regarding ampicillin and penicillin false resistance with clinical isolates and out-of-range (high) quality control (qc) results on the microstrep plus 1 (mstrp+1) and microstrep plus 2 (mstrp+2) panel lots included in this recall. beckman coulter investigation has confirmed a manufacturing error leading to antimicrobic degradation and the potential for elevated or false resistant results for some antimicrobics (e.G. ampicillin and penicillin) in a portion of the panels within these lots.