Cobas E411 Immunoassay Analyzer (2018-09-24)

Cobas e411 Immunoassay Analyzer Recall Roche Diagnostics is recalling Cobas e411 Immunoassay Analyzer devices used in laboratories and medical facilities across Canada. The devices can produce inaccurate test results under certain conditions, which could affect patient care decisions. This is a Class I recall, indicating the most serious type of safety issue.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-10-19

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/eed359a3-5f77-4634-bef6-255582651204