Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DxI 9000 Access Immunoassay Analyzer C11137 Recalled by Beckman Coulter, Inc. Due to Analyzer has calibration issues where curves switched from...
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
DxI 9000 Access Immunoassay Analyzer C11137
Quantity: 67 US; 178 OUS
Why Was This Recalled?
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Beckman Coulter, Inc.
Beckman Coulter, Inc. has 79 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report