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
System, blood culturing - Product Code MDB
원인
The product may mislabel patient information on culture specimen bottles due to a software miscommunication.
조치
BIOMERIEUX sent an Urgent Product Correction Notice to all affected customers starting on October 16, 2012, The letter identified the affected product, the problem, and the action to be taken by hte customer. The firm provided modified instructions for use to clarify how to properly load bottles and to provide appropriate cautions and warnings concerning bottle loading. Customers were instructed to ensure that the letter and guidance on how to properly scan and load bottles is distributed, and training is provided to all appropriate personnel within their organization. Check for lost bottles in their system; fill out and return the Acknowledgement Form in Attachment A by fax to confirm receipt of the notice. Customers were instructed to contact their local bioMerieux Customers Service Representative with any questions.
For questions regarding this recall call 919-620-2682.
Worldwide Distribution - USA including AR, AZ, CA, FL, KS, LA, MD, MN, MT, NC, NV, NY, OR, PA, RI, SC, TX, VA and WA. Internationally to Argentina, Armenia, Austria, Bangladesh, Bosnia and Herzegowina, Brazil, Bulgaria, Burkina FASO, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, COTE DIVOIRE, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LITHUANIA, MALTA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PERU, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, UNITED STATES, URUGUAY, VENEZUELA, VIETNAM, PALESTINE, AND SERBIA.
제품 설명
bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument || The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.