bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 NO. Part number: 414565. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
Publicado el 14 de agosto de 2013 · Inicio del retiro: 14 de junio de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
A product issue has been identified for customers using software version 6.01 and are interfaced with a Laboratory Information System (LIS). During the update of software from version 5.xx to 6.01, the Bid-directional Computer interface (BCI) antibiotic codes are not updated properly for Cefovecin, Prulifloxacin and Ceftaroline. For the referenced antibiotics, the firm code in the reference table
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Biomerieux Inc
- Distribuidor
- Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Bahrain, Belarus, Benelux, Brazil, Bulgaria, Canada, Chile China, Costa Rica, Croatia, Czech Republic, Dominican Republic, Dutch Antilles, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Korea, Kuwait, Libya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, South Africa, Thailand, Tunisia, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
- Lote
- version 6.01
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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