Irispec Ca/Cb/Cc
Brand(s)
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:
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
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63984
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