Vitros 5, 1 Fs Chemistry System, Vitros 3600 Immunodiagnostic System, Vitros 5600 Integrated System, And Vitros 4600 Chemistry System (2018-10-21)

Recall Summary Ortho Clinical Diagnostics is recalling five VITROS laboratory analyzer systems used in medical facilities across Canada due to a software issue that could cause incorrect test results. The affected systems are the VITROS 5, 1 FS Chemistry System, VITROS 3600 Immunodiagnostic System, VITROS 5600 Integrated System, and VITROS 4600 Chemistry System. This is a Class I recall, meaning there is a serious potential health risk associated with the devices.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-11-15

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/9f74d77c-f98c-4119-a0a9-a2018fd816f8