Vitros® Eci Immunodiagnostic System - Troponin I Es Reagent Pack

Recall Summary The VITROS ECi Immunodiagnostic System - Troponin I Es Reagent Pack has been recalled across Canada due to performance issues with the test. This reagent pack is used in medical laboratories to measure troponin I, a protein measured during heart attack diagnosis. The recall affects all distributed units of this product.

Product
VITROS® ECi Immunodiagnostic System - Troponin I Es Reagent Pack
Reason
Performance
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2023-06-22
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/b9efa97b-84f0-426b-bd16-36e844ac55e6