Reported Oct 8, 2025 · Ongoing
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
DxC 500 AU Module w/ISEDxC 500iWith ISE
- REF
C63522 and DxC 500 AU ModuleDxC 500iWithout ISE
- REF
C6352part of the DxC 500i Clinical Analyzer
- Lot codes and dates
- REF/UDI-DI
C63522/14987666545089C63521/14987666545072
- Software VersionsSW 1.3.3 and 1.3.4
- REF/UDI-DI
- Amount recalled
- 116
Why it was recalled
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress with no errors, may cause processing delays.
This product could cause temporary or reversible health problems — stop using it.
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