Dimension Vista System Enzymatic Creatinine Assay (ecrea) & Exl System Enzymatic Creatinine (ezcr) Assay (2020-05-08)

Recall Summary Siemens is recalling the Dimension Vista System Enzymatic Creatinine Assay (ECREA) and EXL System Enzymatic Creatinine (EZCR) Assay kits across Canada due to issues with these medical devices used to measure creatinine levels in blood samples. These assays are used in clinical laboratories to assess kidney function. The recall affects all units of these products distributed in Canada.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-05-22

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b5ac5eed-7ab3-422b-a6c1-1cd68ecb6d87