Device Recall Synchron Systems No Foam DxC, Reference No. B64130

  • Model / Serial
    All
  • Distribution
    Affected geographies: United Arab Emirates, Curacao, Angola, Argentina, Australia, Bangladesh, Belgium, Bulgaria, Brunei, Canada, Switzerland, Colombia, Costa Rica, Czech Republic, Germany, Ecuador, Egypt, Eritrea, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Ireland, India, Iraq, Italy, Jordan, Japan, Korea, Republic of, Kuwait, Lebanon, Lithuania, Morocco, Macao, Mexico, Malaysia, Netherlands, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, Romania, Serbia, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Swaziland, Thailand, Tunisia, Turkey, Taiwan, China, United States of America (including Puerto Rico), Viet Nam, Mayotte, South Africa.
  • Product Description
    The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel DxC System (chemistry analyzer). All lots of No Foam DxC reagent are affected by this recall.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
  • Source
    USFDA