Hologic—Panther Fusion Tube Trays: May Leak, Causing False or Invalid Test Results
May 26, 2021 | Strategic Insights for Health System
ECRI's complete weekly summary of medical device hazard and recall information is available in ECRI's Health Device Alerts. For more information contact us at firstname.lastname@example.org.
Problem: In a February 26, 2021, Medical Device Recall Notification letter posted by the German Federal Institute for Drugs and Medical Devices (BfArM) and a March 15, 2021, Medical Device Recall Notification letter posted by the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), Hologic states that the above tube trays may leak, potentially causing false-positive or false-negative test results or invalid patient or assay worklists. FDA's Center for Devices and Radiological Health (CDRH) states that the manufacturer initiated...