Devices

Device Recall AutoMate 2500 Family

  • 모델명 / 제조번호(시리얼번호)
    All units in the AutoMate 2500 Family are affected; Serial Numbers - 1107, 4048, 4055, 4025, 4052, 4079, 4091, 4076, 4072, 4073, 4074, 4111, 4097, 1054, 1055, 1048, 1049, 1147, ODL25125-1342, ODL25125-1354, 1251, ODL25255-4530, ODL25255-4531, 4126, 4127, 4169, 4171, 4341, 4324, ODL25255-4536, ODL25255-4535, ODL25255-4397, 4141, 4143, 4144, 4146, ODL25255-4606, 4148, ODL25255-4577, ODL25255-4605, 4302, 4304, 4352, ODL25255-4352, 4330, ODL25255-4419, ODL25255-4534, ODL25255-4416, ODL25255-4401, 4168, 4107, 4255, 4257, 4252, 4256, 4254, 4253, 4236, ODL25255-4437, ODL25255-4443, ODL25255-4444, ODL25255-4438, 4294, 4293, ODL25255-4556, ODL25255-4382, ODL25255-4378, ODL25255-4377, ODL25255-4379, ODL25255-4380, ODL25255-4381, ODL25255-4420, ODL25255-4421
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US nationwide, Algeria, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Macao, Mayotte, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
  • 제품 설명
    AutoMate 2550 "High Speed" Catalog Number ODL25255; AutoMate 1250 "Standard" Catalog Number ODL25125. Chemistry analyzer sample processing and sorting system.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event

제조사

Beckman Coulter Inc.
  • 제조사 주소
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA

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Device Recall AutoMate 2500 Family SampleProcessing System
  • 모델명 / 제조번호(시리얼번호)
    ODL25255-4437 ODL25255-4443 ODL25255-4444 ODL25255-4438
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Distribution to MD only.
  • 제품 설명
    AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. || AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving process. Handling and sorting of samples includes automatic detection of the tube type and cap type (color). Optional features include an Aliquot Module for creation of labeled secondary tubes (including detection of the presence of adequate volume for the requested aliquots) and a Recapper Module to re-seal previously decapped tubes prior to archiving.
  • Manufacturer
    Beckman Coulter Inc.