Device Recall HbA1c

  • 모델명 / 제조번호(시리얼번호)
    Lot/Batch 414553, expiry 28th Jan 2019
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Puerto Rico; International: Portugal, Italy, Turkey, Slovakia, Russia, Thailand and Vietnam
  • 제품 설명
    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

제조사

  • 제조사 주소
    Randox Laboratories Ltd., 55 Diamond Road, Crumlin (North) Ireland
  • 제조사 모회사 (2017)
  • Source
    USFDA