Device Recall TDx/TDxFLx and TDxFLx Carbamazepine Reagents

  • 모델명 / 제조번호(시리얼번호)
    Reagent List 9515-60, lot 03492Q100 and Reagent List 9515-85, lot 04530Q100 that contain insert item number 69-5121/R4
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and internationally through Abbott subsidiaries in Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Uruguay, Argentina, Brazil, Puerto Rico, San Salvador, Canada, Germany, England, Japan, Singapore, Hong Kong, India, Taiwan, Thailand, Malaysia, Pakistan, Korea, Australia, New Zealand, Honduras, Costa Rica, Aruba, Bahamas, Panama, St. Croix, Jamaica and Paraguay.
  • 제품 설명
    Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA