Vitros Eci Immunodiagnostic System, Vitros 5600 Integrated Sytem, And Vitros 3600 Immunodiagnostic System

Recall Summary Ortho Clinical Diagnostics is recalling three laboratory diagnostic systems (VITROS ECI, VITROS 5600, and VITROS 3600) used in hospitals and clinics across Canada due to a software issue that can cause incorrect test results. The systems may produce falsely low or falsely high values for certain blood tests, potentially affecting patient care decisions. This recall affects all healthcare facilities using these devices in Canada.

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2013-02-04

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/abee75eb-1a8f-4f62-81be-a76f7d46a702