Devices

Device Recall ADx

  • 모델명 / 제조번호(시리얼번호)
    List no. 9681-55
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 유통
    Distribution was nationwide, VA/DOD accounts. The foreign distribution was as follows: Mexico, Venezuela, Colombia, Chile, Uruguay, Argentina, Brazil, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Costa Rica, New Zealand and Panama
  • 제품 설명
    ADx Tricyclic Antidepressants Reagent. || Distributed under the following label: || ADx, Abbott Laboratories USA, North Chicago, IL 60064
  • Manufacturer
    Abbott Health Products, Inc.
  • 1 Event

제조사

Abbott Health Products, Inc.
  • 제조사 주소
    Abbott Health Products, Inc., Hwy 2 Km 58.0, Barceloneta PR 00617
  • Source
    USFDA

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Device Recall ADx
  • 모델명 / 제조번호(시리얼번호)
    Product List number: 9681-55.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was nationwide.
  • 제품 설명
    ADx Tricyclic Antidepressants Reagent. Distributed under the following label: ADx Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago, IL 60064
  • Manufacturer
    Abbott Health Products, Inc.
Device Recall ADx Methadone
  • 모델명 / 제조번호(시리얼번호)
    All lots with insert version 69-5997/R4. The corrected insert is version 69-6506/R5.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Colombia, Chile, Argentina, Brazil, Puerto Rico, San Salvador, Canada, England, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand, Honduras, Costa Rica, Bahamas, Panama, Dominican Republic and China.
  • 제품 설명
    ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories HPD/ADD/GPRD