IRISpec CA/CB/CC
Brand(s)
Last updated
Summary
Product
IRISpec CA/CB/CC
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| IRISpec CA/CB/CC | 432-24 and higher | 800-7702 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Beckman Coulter Ireland, Inc.
Lismeehan, Co. Clare, Ireland
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75875
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