Beckman Coulter has become aware of an increase in complaints for intermittent IRISpec CB failures for ketone on the iChemVELOCITY Urine Chemistry System (instructions for use PN 300-4449FH) and DxU 810c IRIS Urine Chemistry System (instructions for use PN C49355AA). If a QC run fails, the system will not allow the operator to run patient samples. The QC run should be repeated and pass successfully before running patient samples. Recall start date: July 16, 2024
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