Devices

Device Recall ACCESS Ostase

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

5 devices with a similar name

Learn more about the data here

Device Recall Access Ostase Calibrators
  • Model / Serial
    Lot Numbers:  013490, 015210, 018854, 020419, 022834, 109632
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • 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 || Ostase Calibrators, Part Number: 37305 || The Access Ostase Calibrators are used to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
    Beckman Coulter Inc.
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.
Device Recall Access Ostase Calibrators
  • Model / Serial
    Lot Numbers: Expiration dates: 013489 11/30/2010  111530 09/30/2011 013490 01/31/2011  113463 10/31/2011 015210 02/28/2011  114259 10/31/2011 018854 03/31/2011  114260 11/30/2011 020419 05/31/2011  115484 12/31/2011 022834 06/30/2011  116658 01/31/2012 109632 07/31/2011
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • 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 Calibrators, Part Number: 37305, || Subsequent Product Code: JIS. || The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
    Beckman Coulter Inc.
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.
Device Recall Access Ostase Reagent
  • Model / Serial
    Lot Numbers: Expiration dates: 011167 04/30/2011  017561 09/30/2011 014486 7/31/2011
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • 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 Reagent, Part Number: 37300, subsequent product code: JIS. || The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Pagets disease.
  • Manufacturer
    Beckman Coulter Inc.