Rchitect Stat High Sensitive Troponin-i Reagent Kit (2016-04-28)

Recall Summary Architect STAT High Sensitive Troponin-I Reagent Kit is being recalled across Canada due to a medical device issue. This is a Class I recall, which is the most serious classification. The reagent kit is used in laboratory testing to measure troponin-I levels in patient blood samples.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2016-05-16

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/c1c7b379-e7bb-4091-9a0f-c114bb15f86f