Health product recall

IRISpec CA/CB/CC

Last updated

Summary

Product
IRISpec CA/CB/CC
Issue
Medical devices - Performance issue
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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