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
Manual antimicrobial susceptibility test systems - Product Code JWY
원인
Qc results were out of range resulting in false resistant strains.
조치
BioMerieux sent an Urgent Product Removal Notices dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Required actions:
¿¿ Please distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred our product.
¿¿ Discontinue using and discard any remaining inventory of Etest¿¿ CEFOTAXIME CT 256 lots reported in table 1.
¿¿ Discuss any concerns you may have regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action.
¿¿ Complete and return the Acknowledgement Form in Attachment A by Fax to confirm receipt of this notice and to request product replacement.
bioM¿¿rieux is committed to providing our customers with the highest quality product possible. We sincerely apologize for any inconvenience that this may have caused you. If you require additional assistance or have any questions, please contact your local bioM¿¿rieux Clinical Customer Service organization at (800) 682-2666.
Worldwide Distribution - USA (nationwide) to the states of AL, AR, CA, CO, FL, GA, IL, IN, KY, MD, MI, MN, MO, NE, NY, NC, OH, OK, OR, PA, TN, TX, UT, VA, WA, WV and WI., and to the countries of: Austria, Australia, Canada, Switzerland, Germany, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Netherlands, Poland, Sweden, Thailand, Turkey, Saudi Arabia, Philippines, Slovenia, Kuwait, Brazil, Chile, Czech Republic, Algeria, South Africa, Kosovo, Costa Rica, Belarus, Guam, Honduras and Vietnam.
제품 설명
Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.