Dvia Centaur (cp) System-troponin I Ultra (tni-ultra) Assay(2016-05-04)

Recall Summary Siemens is recalling the ADVIA Centaur (CP) System-Troponin I Ultra (TNI-Ultra) Assay used in Canadian hospitals and laboratories because the device may produce inaccurate test results. This assay is used to measure troponin levels in blood samples to help diagnose heart conditions. The recall affects healthcare facilities across Canada that use this testing system.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2016-05-24

Status

Closed

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/fdf5240a-fce0-48f3-994c-6f6dd433d33a