Dimension Clinical Chemistry System And Xpand System - Lipase Flex (lipl) Assay, And Dimension Exl System - Lipase (lipl) Assay (2017-12-17)

Recall Summary Siemens Healthineers is recalling Lipase assay reagents used with Dimension clinical chemistry analyzer systems across Canada because the reagents may produce inaccurate test results. The affected products are Lipase Flex assay for Dimension Clinical Chemistry and Xpand systems, and Lipase assay for Dimension EXL systems. Healthcare facilities and laboratories using these systems are affected.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-01-09

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/29448f30-f92e-4e9a-88d2-a43fe55a2ab7