Device Recall PROT 1 CON H

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 6EQH01, 6EQH01A, 6EQH01B, 6EQH01C (exp. date 2017-09-17); 6LQH01A, 6LQH01B, 6LQH01C (exp. date 2018-04-04). ---  Lot # (UDI): 6EQH01 (008427680063576EQH0120170917),  6EQH01A (008427680063576EQH01A2017091),  6EQH01B(008427680063576EQH01B20170917),  6EQH01C(008427680063576EQH01C20170917),  6LQH01A (008427680063576LQH01A20180404),  6LQH01B (008427680063576LQH01B20180404),  6LQH01C (008427680063576LQH01C20180404).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) Internationally to Austria, Australia, Belgium, Canada, France, Germany, Great Britain, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Switzerland and Republic of Korea South
  • 제품 설명
    Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717; IVD.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Healthcare Diagnostics, Inc., 500 Gbc Dr Ms 514, PO BOX 6101, Newark DE 19702-2466
  • 제조사 모회사 (2017)
  • Source
    USFDA