Official recall record
IRISpec CA/CB/CC (ref 75875)
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2024-07-26
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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