Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
Publicado el 8 de marzo de 2017 · Inicio del retiro: 10 de enero de 2017
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
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT Systems. In addition, Siemens Healthcare Diagnostics confirmed the potential for calibration failures due to above limit calibrator RLU %CVs when using Calibrator A kit lots ending in 90 with the FT4 assay. The performance of the FT4 assay when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur CP System is not affected. Customers may continue to use Calibrator A kit lots ending in 90 for the ADVIA Centaur Systems FT3, T3, T4 and TUp assays.
Detalles del retiro
- Fabricante
- Siemens Healthcare Diagnostics, Inc
- Distribuidor
- Nationwide. Afghanistan, Albania, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Latvia, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vatican, Vietnam
- Lote
- Lot Numbers: 08722A90 27210A90 43429A90 Exp. Date: 2017/07/24
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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