Vitros Chemistry Products 5,1 Fs Chemistry System - Dldl Assay (2018-10-08)

VITROS Chemistry Products 5,1 FS Chemistry System - dLDL Assay Recall Ortho Clinical Diagnostics is recalling VITROS Chemistry Products 5,1 FS Chemistry System dLDL Assay kits distributed across Canada. The dLDL (direct low-density lipoprotein) assay component of this blood testing system is being recalled due to a defect with the medical device. This recall affects laboratories and healthcare facilities that use this system to measure cholesterol levels in patient blood samples.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-11-02

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/99871aeb-9c97-49ae-8c7f-29f579bd0836