FDA-Device2013-05-01Class II
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and in selective electrode.
Beckman Coulter Inc.
Hazard
Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 system.
Sold states
Worldwide Distribution - USA, including Canada and Puerto Rico and the states of NJ, TX, CA, UT, KS, MA, NY, MI, GA, VA, IN, WI, IL, OH, NV, NC and PA. and the countries of Australia, Belgium, Czech Republic, Japan, Germany, Brazil, China, Italy, Ireland, Israel, India, Hong Kong, Malaysia, Netherlands, Spain, Switzerland, France, Taiwan, Turkey, United Kingdom and Vietnam.
Affected count
490
Manufactured in
250 S Kraemer Blvd, Brea, CA, United States
Products
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, turbidimetric, latex agglutination, homogeneous enzyme immunoassay, and in selective electrode.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1167-2013Don't want to check this manually?
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