Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DxI 9000 Access Immunoassay Analyzer Recalled by Beckman Coulter, Inc. Due to The firm has investigated and confirmed that when...
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, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Quantity: 36 units
Why Was This Recalled?
The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.
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