Vitros Chemistry Products System - CKMB Slides (Creatine Kinase Mb)
Brand(s)
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:
Alert / recall type
Health product recall
Category
Health products - Medical devices
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
Get notified
Receive notifications for new and updated recalls and alerts by category.