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
Brain Heart Infusion IVD - Product Code JSC
원인
Product failure - failure to grow quality control strains of streptococcus pneumoniae.
조치
The recalling firm issued separate recall letters dated December 21, 2009 addressed to Microbiology Laboratory Supervisors or Distributors explaining the reason for recall and requesting all remaining product be discarded. A Product Inventory Checklist was enclosed to report the amount of product that was discarded by the customer. The Distributor letter requests the consignee contact their customers to notify them of the recall. Direct inquiries concerning this recall to the Technical Services Department at 1-800-255-6730 (United States) or 1-913-888-0939 (International).
Oxoid CM0225 Brain Heart Infusion IVD. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. || The product is used for the cultivation of streptococci, pneumococci, meningococci and other fastidious organisms and is suitable for blood culture work.