Device Recall HbA1c

  • Modelo / Serial
    Lot/Batch 414553, expiry 28th Jan 2019
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam
  • Descripción del producto
    Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml || HbA1c R2: Agglutinator Reagent - 3 x 14 ml || R3: Haemoglobin Denaturant Reagent - 3 x 50 ml || Hb R1: Total Haemoglobin Reagent - 3 x 28 ml || For Professional Use in the quantitative in vitro determination of Haemoglobin A1c concentration in whole blood.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Randox Laboratories Ltd., 55 Diamond Road, Crumlin (North) Ireland
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA