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

565-22 and higher

800-7211

Issue

Beckman Coulter has become aware of an increase in customer complaints generated for intermittent Irispec Cb glucose control false positive results when used in conjunction with ichemvelocity urine chemistry strips PN 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 be successful before running patient samples ([ichemvelocity urine chemistry system instructions for use (IFU) P/N 301-7146be, chapter 4; quality control). This issue affects Irispec Cb control lot numbers 565-22 and higher when analyzed with ichemvelocity urine chemistry strips (pn 800-7212) lot numbers 7212554m and higher. There is no impact to patient results, Irispec Ca or Cc controls. 

Recall start date: November 14, 2022

Additional information

Details
Original published date: 2022-11-25
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
Healthcare
Recall class
Type II
Identification number
RA-72217