Health product recall

Vitros Chemistry Products System - Eco2 Slides (Carbon Dioxide)

Last updated

Summary

Product
Vitros Chemistry Products System - Eco2 Slides (Carbon Dioxide)
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 catalogue number
Vitros Chemistry Products System - Eco2 Slides (Carbon Dioxide) 5732-3598- 4651 5732-3598-4650 826 2396

Issue

Ortho Cinical Diagnostics (quidelortho) has determined that some lots from coating 3598 of Vitros Eco2 Slides include carts which may contain consecutive slides that may not function as intended. These affected Vitros Eco2 slides (potentially intermittent, consecutive slides within a cart or across consecutive carts) have an abnormality which may cause positively or negatively biased results. Due to the nature of the abnormality, which can vary across the affected slides, the magnitude of potential bias can vary from slide to slide.

Recall start date: October 26, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive, Rochester, New York, United States, 14626
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74641