Dvia Chemistry System - High Sensitivity C-reactive Protein(hscrp) Assay (2019-11-21)

Summary Siemens Healthineers is recalling the ADVIA Chemistry System High Sensitivity C-Reactive Protein (HSCRP) Assay across Canada due to a defect in the medical device. The HSCRP Assay is used in clinical laboratories to measure inflammation markers in patient blood samples. This is a Class I recall, indicating a serious issue with the product.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-01-06

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/c38789b0-13a3-4e9e-b644-ca475c3a9486