Rotem Rotrol N Normal Control For Thromboelastometry (2019-07-10)

Recall Summary ROTEM ROTROL N Normal Control for Thromboelastometry has been recalled across Canada due to issues with the medical device. This product is a control sample used to verify that thromboelastometry equipment (machines that measure blood clotting) is working correctly. The recall is classified as Class I, meaning there is a serious potential health risk associated with the product.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-08-09

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/4b93c9df-e6d0-4400-91c8-cae60f4f1c3a