Health product recall

Irispec Ca/Cb/Cc

Last updated

Summary

Product
Irispec Ca/Cb/Cc
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Irispec Ca/Cb/Cc

CA control 583-21 and higher

800-7211

Issue

Beckman Coulter has become aware of an increase in complaints generated for Irispec Ca failures for glucose on the ichemvelocity instrument. If a Qc run fails, the system will not allow the operator to run specimens. The Qc run should be repeated and be successful before running patient specimens. This issue affects Irispec Ca control lot number 583-21 and higher when analyzed with ichemvelocity urine chemistry strips lot number 7212510m and higher. There is no impact to patient results, Irispec Cb or Cc controls.

Recall start date: Feb 14, 2022

Additional information

Details
Original published date: 2022-03-17
Alert / recall type
Health product recall
Category
Health product - Medical device - Chemistry
Companies

Beckman Coulter Ireland, Inc.

Lismeehan, Co. Clare

Ireland

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63984