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 LABORATORY SYSTEMS (SUZHOU) CO., LTD. Due to Beckman Coulter has identified an issue which prevents...
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 LABORATORY SYSTEMS (SUZHOU) CO., LTD. directly.
Affected Products
DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected software.
Quantity: 56
Why Was This Recalled?
Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.
Where Was This Sold?
This product was distributed to 18 states: AL, CA, CO, GA, ID, IL, LA, MA, MI, MN, MS, NY, OK, OR, PA, SC, TX, WA
About BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD.
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report