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.
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원인
The firm inventoried and distributed 0.9% sodium chloride saline bags as 0.45% sodium chloride saline bags for use with the vitek 2 system.
조치
Biomerieux sent an Urgent Product Removal Notice letter dated October 16, 2012 to all affected customers via certified mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the affected product and immediately discard any remaining inventory. The letter included instructions on receiving product replacement or credit. For questions or concerns contact your local BioMerieux representative.
Worldwide Distribution - USA (nationwide) including the states of: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, TN, TX, VA and WI. Distribution was also made to Canada, military facilities and other foriegn countries.
제품 설명
0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter || Product Usage: || The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride injections, and the system is designed to use 0.45%-0.50% sodium chloride concentration only.