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
Stains, microbiologic - Product Code JTS
원인
The product may appear cloudy or discolored and may not perform correctly in presumptive diagnosis of mycobacterial disease.
조치
Thermo Fisher Scientific sent a Medical Device Recall letter dated October 29, 2014, to all affected customers. The letter notified customers that Remel, Inc., a part of Thermo Fisher Scientific, was voluntarily recalling the affected product. Customers were instructed to notify any personnel who need to be notified of the potential for false negative results. Customers should review results reported using this lot and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response form acknowledging receipt of the notice and disposal of the affected product.
Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
For questions regarding this recall call 913-888-0939.
Worldwide Distribution to USA including AL, CA, CO, IA, MO, NC, NY, NV, OH, PA, SC, SD, TN, TX, VA, WI and Internationally to Canada.
제품 설명
Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. || A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.