Dimension Vista Lipase (lipl), Dimension Clinical Chemistry, Exl And Xpand System - Lipase Flex (lipl) Assay (2018-09-13)

Siemens is recalling Dimension Vista Lipase, Dimension Clinical Chemistry Lipase Flex, and related assay products used in hospital and laboratory testing equipment because these devices may produce inaccurate test results. The recall affects lipase assay reagents and calibrators distributed across Canada. This recall involves medical devices classified as Class I, indicating a serious potential health risk.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2018-10-05

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/1deebabe-178e-4a7c-ac89-ccfa0d43c3a7