Abbott

  • 모델명 / 제조번호(시리얼번호)
    (List Number On the Box---List Number On the bottle---Lot Number):  99226-01---99229-01---15632I2; 08H17-01---08H17-02---15631I2; 08H17-01---08H17-02---15661I2;  08H17-01---08H17-02---16823I2;  08H17-01---08H17-02---17906I2;  08H17-01---08H17-02---17907I2;  08H17-01---08H17-02---18089I2; 08H17-01---08H17-02---19184I2;  08H17-01---08H17-02---19296I2;  08H17-01---08H17-02---20413I2;  08H17-01---08H17-02---21540I2;  08H17-01---08H17-02---22739I2;  08H17-01---08H17-02---23889I2    Expanded: All lots under recall.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution of DILUENT is worldwide to a total of 1,584 consignees. All CELL-DYN 1800 customers were notified via the Device Recall Letter. At the time of receipt of the letter, the customer may or may not have the recalled lots in their inventory. Therefore, the letter directed the customer to assess their inventory of DILUENT 08H17-01 and 99226-01 to determine if they had any of the affected lots in their possession. Foreign countries include: Canada, Columbia, Uruguay, Germany, Barbados, Bermuda, Cayman Islands.
  • 제품 설명
    Abbott brand CELL-DYN 1800 DILUENT Packaged in 3.8L containers, || List Numbers: || 99226-01, 08H17-01,(on box), 99226-01, 08H17-02 (on bottle); || Product is distributed by Abbott Hematology, 5440 Patrick Henry Dr., Santa Clara, CA 95054
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Abbott Laboratories, 5440 Patrick Henry Dr, Santa Clara CA 95054-1113
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    ALINITY CI-SERIES MODULE, all serials.
  • 제품 설명
    It is a fully automated immunoassay system that allows random and continuous access, as well as priority processing and automatic re-analysis using chemoluminescent micro-particle immunoassay technology. CMIA technology is used to determine the presence of antigens, antibodies and analytes in samples. The scalable design of the ALINITY I allows one or more sample processing modules, in multiple configurations, with a system control module to physically join together to form a single workstation.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Endovascular closure device designed for the closure of the femoral artery after percutaneous catheterization procedures.
  • Manufacturer
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