Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Recalled by Beckman Coulter Inc. Due to Beckman Coulter, Inc. initiated this recall because there...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter Inc. directly.
Affected 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.
Quantity: 490
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 17 states: CA, GA, IL, IN, KS, MA, MI, NV, NJ, NY, NC, OH, PA, TX, UT, VA, WI
About Beckman Coulter Inc.
Beckman Coulter Inc. has 241 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report