Reported May 21, 2025 · Ongoing
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The…
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 Clinical Chemistry Analyzer
- Catalog Numbers/UDI codesC63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only
- Lot codes and dates
- Catalog NumberC63519
- UDI-DI code14987666545058
- Serial NumbersCatalog
- NumberC63520
- UDI-DI code14987666545065
- Serial Numbers—
Where it was sold
Why it was recalled
Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or calibration is ordered during sample processing and then any of the components (R1 and/or R2) depletes to zero tests, the analyzer will not be able to complete the calibration request, and the calibration order will remain pending. No further calibration orders can be processed for any assays, and the instrument refuses to accept further sample processing order after the existing calibration curves are expired. Although in-process tests will be completed, this error can cause a delay in reporting subsequent test results. No further calibration orders can be processed for any assays which may cause a delay in reporting test results.
This product could cause temporary or reversible health problems — stop using it.
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