Rchitect System - Analyzer - Class 2, Architect C4000 And C16000 Processing Modules, Architect C4000 System - Integrated Processing Module (2019-05-02)

Recall Summary Abbott is recalling certain ARCHITECT System analyzers and processing modules used in medical laboratories across Canada due to a potential device malfunction. The affected products include the ARCHITECT System Analyzer, ARCHITECT c4000 and c16000 Processing Modules, and the ARCHITECT c4000 Integrated Processing Module. This recall applies to devices distributed throughout Canada.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2019-05-17
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/2f3d0323-4be6-4052-8504-6ce738bb4eaa