Device Recall iChem VELOCITY Automated Urine Chemistry System

  • Modèle / numéro de série
    Catalog 700-7176-001 - Serial numbers V04494 and CV04015;   Catalog 700-7177-001 - Serial numbers CV04012, CV04013, CV04014, and CV04017.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: AL, IA, GA, and FL.
  • Description du dispositif
    iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. || The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in a iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
  • Source
    USFDA

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    all serial numbers
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Affected geographies: Argentina, Australia, Austria, Bangladesh, Bermuda, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Canada, Chile, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mexico, Montenegro, Netherlands, New Zealand, Nigeria, Oman, Panama Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico , Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Republic, United States (including Puerto Rico), and Venezuela
  • Description du dispositif
    iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 || iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001
  • Manufacturer