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Beckman Coulter Inc. recalls AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry a
Recalled May 1, 2013 · FDA recall Z-1167-2013 · Beckman Coulter
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. · FDA Class II
Units
490
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →