Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DxC 500 AU Clinical Chemistry Analyzer Recalled by Beckman Coulter Mishima K.K. Due to Due to a software issues, after the instrument...
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 Mishima K.K. directly.
Affected Products
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 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.
Quantity: 24 analyzers
Why Was This Recalled?
Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Beckman Coulter Mishima K.K.
Beckman Coulter Mishima K.K. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report