Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer Recalled by Beckman Coulter, Inc. Due to When the DxI 9000 Access Immunoassay Analyzer with...
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
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Quantity: 164 units
Why Was This Recalled?
When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.
Where Was This Sold?
This product was distributed to 9 states: FL, GA, IN, KS, NH, NJ, OK, PA, TX
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