Cobas 8100 Brf System

Cobas 8100 BRF System Recall Summary Roche Diagnostics is recalling the Cobas 8100 BRF (Body Fluid Reagent Flex) System across Canada due to a software issue that can cause incorrect test results. The system is used in hospitals and laboratories to analyze body fluids for diagnostic testing. This recall affects all Cobas 8100 BRF Systems currently in use.

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2017-04-13

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/13b45fc0-d99a-473c-9052-02ab7e3d56ce