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
Urinalysis controls (assayed and unassayed) - Product Code JJW
원인
The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. this results in the instrument not passing controls and the customer not being able to run patient samples.
조치
IRIS sent a Medical Device Recall letter dated September 18, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to dispose of all unopened or partially used inventory, complete the attached worksheet certifying the disposal of the affected product and email or fax to Iris Diagnostics.
Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.
제품 설명
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. || Product Usage: For in vitro diagnostic use with the iQ200 series.