Regulatory Affairs Syndicator

Main Category: Blood / Hematology Also Included In: Clinical Trials / Drug Trials Article Date: 24 May 2009 Seattle Genetics, Inc.

This device is used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitor detects and alarms for periods of temporary interruption of breathing (central apnea) or low heart rates.

Reason for Recall: The use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, CK-MB, and myoglobin, possibly resulting in missed or incorrect diagnosis.

REPEL-CV Bioresorbable Adhesion Barrier is a single use, synthetic, bioresorbable polymeric film composed of poly-lactic acid (PLA) and polyethylene glycol (PEG).