Architect "i" System - I2000sr Processing Module - Class 4

Recall Summary Abbott Laboratories is recalling the ARCHITECT "I" System i2000SR Processing Module in Canada due to a device performance issue. The recall affects all units of this laboratory processing module that were distributed across Canada. This is classified as a Class II recall, indicating a potential health hazard situation.

Product

ARCHITECT "I" System - i2000SR Processing Module - Class 4

Reason

Device performance issue

Classification

Class II

Category

medical device recall

Country

Canada

Agency

HC-DEVICES

Recall date

2026-10-16

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/a23d6563-2b6a-49b6-8433-3286b539378d