Device Recall HbA1c

  • Modèle / numéro de série
    Lot/Batch 414553, expiry 28th Jan 2019
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Randox Laboratories Ltd., 55 Diamond Road, Crumlin (North) Ireland
  • Société-mère du fabricant (2017)
  • Source
    USFDA