Reported Aug 7, 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 · 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
There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. Issue 2: calibration with expired calibrator. They both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely.
This product could cause temporary or reversible health problems — stop using it.
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