Rchitect C8000 Analyzer, Architect C16000/c4000 Processing Module And Architect C4000 Integrated Processing Module (2017-12-13)

Abbott is recalling ARCHITECT C8000 Analyzer, ARCHITECT C16000/C4000 Processing Module, and ARCHITECT C4000 Integrated Processing Module devices distributed across Canada because they are classified as medical devices requiring proper regulatory approval. This is a Class I recall, which indicates a serious issue. The recall affects these laboratory analyzer systems that were in distribution throughout Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2017-12-21

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/e5a07046-e44b-4f39-abed-62c1631400e7