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 There are two software bug issues with the...
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?
There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. Issue 2: calibration with expired calibrator. They both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely.
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