VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Publicado el 8 de febrero de 2017 · Inicio del retiro: 20 de diciembre de 2016
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
There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after using the minimum warm up requirements stated in the IFU. If Quality Control (QC) results are within acceptable limits, reported results are acceptable and were not affected by this issue.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Ortho-Clinical Diagnostics
- Distribuidor
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
- Lote
- Generation (GEN): 1 through 6, 30 through 40, 44 through 49 Expiry Dates: 01-JAN-2017 through 01-JUN-2018
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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