Reported Aug 28, 2024 · Ongoing
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in…
Beckman Coulter Mishima K.K.
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 Mishima K.K. · 454-32 · Sunto-Gun · N/A
Is this the product you have?
- DxC 500 AU Clinical Chemistry Analyzer, REF C63520 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 NumberC63520
- UDI-DI code14987666545065
- Serial Numbers
202307001020230600052023090015202307000920230800112023080012202310001920231000182023100020202401003720240100362023110022202401003820230900162024020040202402004120240200392024020043202402004220231100232024020045202402004620240100242024010025
- Amount recalled
- 24 analyzers
Where it was sold
Why it was recalled
Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.
This product could cause temporary or reversible health problems — stop using it.
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