Device Recall PROT 1 CON M

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 6BQM01, 6BQM01A, 6BQM01B, 6BQM01C,6BQM01D, 6BQM01E (exp. date 2017-06-17); 6FQM01, 6FQM01A (exp. date 2017-11-03) ---  Lot # (UDI): 6BQM01 (008427680063336JQL01C20180131),  6BQM01A (008427680063406BQM01A20170617),  6BQM01B (008427680063406BQM01B20170617),  6BQM01C (008427680063406BQM01C20170617),  6BQM01D( 008427680063406BQM01D20170617),  6BQM01E (008427680063406BQM01E20170617),  6FQM01(008427680063406FQM0120171103),  6FQM01A (008427680063406FQM01A20171103).
  • 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 M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product Code KC716; 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