Cobas 4800 System Sample Preparation Kit 2 (2019-12-02)

Recall Summary The Cobas 4800 System Sample Preparation Kit 2 is being recalled across Canada due to a medical device issue. This product is used in laboratory testing systems. The recall is classified as Class I, meaning there is a serious potential health risk associated with the device.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-01-06

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b62e919b-c894-4189-9b5d-99f46c8aa2a2