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
Real Time Nucleic Acid Amplification System - Product Code OOI
원인
The nuclisens easyq enterovirus reagents are unable to detect enterovirus serotype 68, in respiratory samples.
조치
BioMerieux Vitek, Inc. sent an "Urgent Product Correction Notice" letter on/about May 10, 2011.
The letter included; a description of the product, problem, possible impact to the patient and recommendations. Recommendations included instructing customers to discontinue the use of the kit for the detection of Enterovirus 68 and Rhinovirus 87 serotypes and noted the corrected IFU will be available the first week of April 2011. An Acknowledgement form was attached to be returned via fax.
For additional questions please contact your local BioMerieux Clinical Customer representative at (800) 682-2666, option 3, option 2.