Cobas 8000 E602 Immunoassay Analyzer

Cobas 8000 E602 Immunoassay Analyzer Recall Roche Diagnostics is recalling the Cobas 8000 E602 Immunoassay Analyzer, a laboratory device used to test blood samples, due to a software issue that could cause inaccurate test results. The recall affects medical laboratories and hospitals across Canada that use this analyzer. This is a Class I recall, which means there is a reasonable possibility the product could cause serious harm or death.

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2017-03-31

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/bf5e7dd7-d00c-4e0d-8099-c78ef16ffd9b