Company: Beckman Coulter, Inc.
Date of Enforcement Report: 5/1/2013
Class ll:
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. Recall Number Z-1167-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA on 3/20/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
490
DISTRIBUTION
Nationwide and Internationally
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