The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. The box contains 4 vials with 25 microcuvettes in each vial.
Publicado el 9 de julio de 2025 · Inicio del retiro: 12 de mayo de 2025
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
Glucose microcuvettes experienced transit time outside of limits, so stability through the whole microcuvette lifetime can no longer be guaranteed. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency, and purity of the product. This failure could increase the probability of an incorrect test result or a delayed test result.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- HemoCue AB
- Distribuidor
- US Nationwide distribution in the state of AR.
- Lote
- UDI-DI: 07311091107060, Lot: 2501708 (Only 4 boxes within specific McKesson Shipment)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Sweden
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