Vitros 3600 Immunodiagnostic System, Vitros 5600 Integrated System, Vitros Xt 7600 Integrated System (2019-02-21)

Recall Summary Ortho Clinical Diagnostics is recalling three VITROS laboratory testing systems (models 3600, 5600, and XT 7600) distributed across Canada due to a defect in the devices. These systems are used in medical laboratories to run diagnostic tests on patient samples. The recall is classified as Class I, meaning there is a serious risk to health.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-03-08

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/67a0f5f2-4dc7-447b-b8ca-bf5dc8c76d5c