FDA-Device2014-02-26Class II
Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Beckman Coulter Inc.
Hazard
The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.
Sold states
Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
Affected count
3 units
Manufactured in
250 S Kraemer Blvd, Brea, CA, United States
Products
Access 2 Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0984-2014Don't want to check this manually?
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