Health product recall

Vitros Chemistry Products System - CKMB Slides (Creatine Kinase Mb)

Last updated

Summary

Product
Vitros Chemistry Products System - CKMB Slides (Creatine Kinase Mb)
Issue
Medical devices - Inaccurate test or measurement results
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or serial number

Model or catalog number

Vitros Chemistry Products System - CKMB Slides (Creatine Kinase Mb)

coating 0245

800 1133

Vitros Chemistry Products System - CKMB Slides (Creatine Kinase Mb)

coating 0245

805 8232

Issue

The affected vitros CKMB slides coating does not adequately inhibit CK-mm up to a total CK more than 1000 u/L. Therefore, samples with a total CK value less than 1000 u/L may exhibit falsely elevated vitros CKMB slides results.

Recall start date: Nov 30, 2021

Additional information

Details
Original published date: 2021-12-10
Alert / recall type
Health product recall
Category
Health product - Medical device
Companies
Ortho-Clinical Diagnostics Inc.

100 Indigo Creek Drive, Rochester, New York

United States, 14626

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63695