Vitros Eci Immunodiagnostic Products (2018-11-01)

VITROS ECi Immunodiagnostic Products Recall Ortho Clinical Diagnostics is recalling VITROS ECi immunodiagnostic products used in laboratories across Canada due to a manufacturing defect that could affect test result accuracy. These are medical devices used by healthcare facilities to run diagnostic tests on patient samples. This is a Class I recall, meaning there is a serious risk to health.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-11-28

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/d2d1d19d-205c-49f0-bc65-9f5c43c87702