Rchitect, Alinity I Estradiol Reagent Kits (2019-02-09)

Recall Summary Abbott Diagnostics is recalling Architect and Alinity i Estradiol Reagent Kits distributed across Canada. The reagent kits are used in laboratory testing equipment to measure estradiol levels in patient blood samples. The kits were recalled because they are classified as medical devices that do not meet safety and effectiveness requirements.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-02-22

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/8cd9eefc-37c6-44a6-8e14-839fcd4a63ec