System Control N+p, Sta - Coag Control N+p & Unicalibrator - Sta (2019-11-19)

Recall Summary Stago is recalling System Control N+P, STA - Coag Control N+P, and Unicalibrator - STA blood coagulation control and calibration products distributed across Canada due to issues with these medical devices. The recall is classified as Class I, indicating a serious potential health risk. These products are used in laboratories to verify the accuracy of blood clotting tests.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-12-13

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/2580c25c-9a43-45fd-aee5-8b3602437b96