Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Beckman Coulter DxA Automation System Recalled by Beckman Coulter Biomedical GmbH Due to A software defect in the DxA Automation System...
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 Biomedical GmbH directly.
Affected Products
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Quantity: 146 systems
Why Was This Recalled?
A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
Where Was This Sold?
This product was distributed to 19 states: AL, CA, FL, IL, IN, KY, MI, MN, MO, NE, NV, NJ, NY, OH, PA, SC, TX, WV, WI
About Beckman Coulter Biomedical GmbH
Beckman Coulter Biomedical GmbH 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