Device Recall Hemoglobin Test Kits

  • 모델명 / 제조번호(시리얼번호)
    Catholyte Solution Batch Lot #235867, included in kits labeled with Kit Lot Numbers: 234172, 234177, 234182, 234190, 234195, 234200, 234205, 234222, 234231, 234240, 234247, 234252, 234257, 234262, 234267, 234272, 234277, 238917, 238920 & 238923.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The recalled kits were distributed to customers in the following locations: FL, OK, GA, MD, AZ, KY, NY, PR, OR, NJ, WA, MI, KS, AR, IN, TX, MN, CA, VA, NC, DE, UT, WI, SC, OH, MT, KS, CO & PR.
  • 제품 설명
    RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    PerkinElmer LAS Inc, 3985 Eastern Rd, Norton OH 44203-6215
  • Source
    USFDA