Benchmark Ultra Automated Immunostaining System & Benchmark Xt (2020-04-08)

Recall Summary Roche Diagnostics has recalled the Benchmark Ultra and Benchmark XT automated immunostaining systems across Canada due to a software issue that could cause incorrect staining results on tissue samples. This affects healthcare facilities and laboratories that use these devices for diagnostic testing. The recall is classified as Class I, meaning there is a potential serious adverse health consequence.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-05-08

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/1fe9fa54-30dd-4dd0-ae08-c14ce69512a7