Public recall detail

Vitros Chemistry Products System - Eco2 Slides (Carbon Dioxide)

2023-11-24

medium
Recall Safety notice
Quick summary

Quick summary: Vitros Chemistry Products System - Eco2 Slides (Carbon Dioxide). Date: 2023-11-24.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Vitros Chemistry Products System - Eco2 Slides (Carbon Dioxide). Date: 2023-11-24.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandORTHO-CLINICAL DIAGNOSTICS INC.
ProductVitros Chemistry Products System - Eco2 Slides (Carbon Dioxide)
IssueMedical devices - Performance
Recall classType II
IdentificationRA-74641

Affected products

ProductVitros Chemistry Products System - Eco2 Slides (Carbon Dioxide)
Lot5732-3598- 4651 5732-3598-4650
Model826 2396
Serial number5732-3598- 4651 5732-3598-4650
DescriptionVitros Chemistry Products System - Eco2 Slides (Carbon Dioxide)

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesOrtho-Clinical Diagnostics Inc. 100 Indigo Creek Drive, Rochester, New York, United States, 14626
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74641
Background{}
CompaniesOrtho-Clinical Diagnostics Inc. 100 Indigo Creek Drive, Rochester, New York, United States, 14626
AudiencesHealthcare
Source updated2023-11-24

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...