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• Class I Medical Device Recall: Roche Diagnostics Operations, Inc., Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays - With certain types of plasma samples, doctors may receive a falsely low result (up to a maximum of 50% lower than the actual concentration of Troponin I). These incorrect results may cause serious adverse health consequences, including death.
• Consumer Information on: BOND? ORACLE? Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemical (IHC) System - P090015 - The BOND? ORACLE? Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemical (IHC) System is a laboratory test that measures how much HER2 protein is being made by breast cancer cells. The test uses a technique that will specifically recognize..
• Consumer Information on: Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD) - H100004 - The EXCOR® Pediatric VAD is a blood pump that vibrates rhythmically and is designed to assist patients who cannot pump enough blood with their own natural heart. The device can be used in patients who cannot effectively pump blood with their left and/or..
• Consumer Information on: Epic? Vascular Self-Expanding Stent System - P110035 - The Epic? Vascular Self-Expanding Stent System is a thin, flexible, metal mesh tube that is implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). It consists of two parts, the stent and the delivery system. The stent..
• Consumer Information on: Presillion plus CoCr Coronary Stent on RX System - P110004 - The Presillion plus CoCr Coronary Stent on RX System is a metal stent that is mounted on a folded balloon attached to a catheter delivery system for placement into a blood vessel supplying blood to the heart (coronary artery). The stent is made of a...