Devices

Device Recall Access Ostase QC

  • Model / Serial
    Lot Numbers: Expiration dates: 009091 10/10/2010  109636 09/30/2011 013491 10/31/2010  113465 10/31/2011 013492 11/30/2010  113969 10/31/2011 014488 12/31/2010  114261 11/30/2011 015211 02/28/2011  115485 12/31/2011 018855 03/31/2011  116660 01/31/2012 020420 04/30/2011  118211 02/28/2012 021285 05/31/2011
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, India,Ireland, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, Netherlands, New Zealand, Panama, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.
  • Product Description
    Access Ostase QC, Part Number: 37309. || The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
  • Manufacturer
    Beckman Coulter Inc.
  • 1 Event

Manufacturer

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

One device with a similar name

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Device Recall Access Ostase QC
  • Model / Serial
    Lot Numbers:  911585, 015211, 018855, 020420, 021285, 021640
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide in US and worldwide to: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, New Zealand, Panama, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom
  • Product Description
    Access Immunoassay Systems || Quality Control Kits, Part Number: 37309 || The Access Ostase QC is used for monitoring system performance of the Access Ostase assay.
  • Manufacturer
    Beckman Coulter Inc.