Dimension Vista System-enzymatic Creatinine (ecrea) Assay And Dimension Exl System-enzymatic Creatinine (ezcr) Assay (2019-12-24)

Recall Summary Siemens Healthineers is recalling the Dimension Vista System-Enzymatic Creatinine Assay and Dimension EXL System-Enzymatic Creatinine Assay across Canada due to a defect in these laboratory testing devices. These assays are used to measure creatinine levels in patient blood samples to assess kidney function. The recall affects healthcare facilities and laboratories that use these Siemens diagnostic systems.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-01-20

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/cdb433db-54b2-4914-bee7-2a9c29edc7bb