Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation.
Publicado el 19 de diciembre de 2018 · Inicio del retiro: 5 de octubre de 2018
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
Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 peaks may be seen and the % HbA1c control values may drift higher than the assigned range. This may result in delays when performing routine instrument quality control. If this issue occurs, there may be a delay in testing and reporting patient test results. Tosoh has received two (2) complaints related to this issue with no serious injuries reported.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Tosoh Bioscience Inc
- Distribuidor
- Distributed nationwide. Foreign distribution to Canada.
- Lote
- Lot 7055
- Clasificación de riesgo
- Class III
- Área (FDA)
- device
- País
- United States
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