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 | 800-7211 800-7702 |
Issue
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB glucose control failure, resulting in false positive results when used in conjunction with iChemVELOCITY Urine Chemistry Strips PNS 800-7204 and 800- 7212.
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-75879
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