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Irispec ca cb cc
Official notice
26 Jul 2024
Last checked
26 Jul 2024
An official Health Canada notice concerns Irispec ca cb cc. 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 Published 2024-07-26.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75875
Official notice
2024-07-26
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Beckman Coulter Ireland, Irispec Ca Cb Cc.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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