FDAFDA · Alimentos y medicamentos·N.º oficial Z-1400-2013
Synchron LX System(s) and UniCel DxC 600/800 System(s) Lactate Reagent, Part Number: A95550 Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX System(s), UniCel DxC 600/800 System(s) and Synchron Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid (CSF).
Publicado el 5 de junio de 2013 · Inicio del retiro: 17 de abril 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
Beckman Coulter initiated the recall for the Lactate Assay (LACT) Lot M206209 as they received a customer complaint of error message (RXN RATE HI), i.e. no numerical values reported for samples containing Lactate concentration greater than 6.5 mmol/L.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Beckman Coulter Inc.
- Distribuidor
- Worldwide Distribution - USA Nationwide and the countries of Canada, Australia, Belgium, Czech Republic, France, French Polynesia, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Jordon, Kuwait, Lebanon, Malawi, Morocco, Namibia, Netherlands, oman, Panama, Paraguay, Qatar, Reunion, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom
- Lote
- Lot Number: M206209
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.