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
Susceptibility test cards, antimicrobial - Product Code LTW
원인
The outer carton label and package insert for the recalled product incorrectly lists streptococcus pneumoniae as an organism for intended use.
조치
Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following:
" Please confirm this letter has been distributed and reviewed by all appropriate personnel within your
organization.
" For the referenced test kits (VITEK¿ 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in
the Package Insert antibiotic table to confirm which organisms can be tested.
" Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae.
" Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms.
" Please store this letter with your bioM¿rieux instrument documentation.
Please complete the attached Acknowledgement Form and return it to bioM¿rieux, Inc.
Customers with questions were instructed to contact their local BioMerieux representative.
For questions regarding this recall call 314-731-8526.
Worldwide Distribution to United Kingdom and Turkey. NO U.S. distribution.
제품 설명
Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per carton, IVD. || Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.