FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Devices Suspended From Australia’s ATRG

Sept. 15, 2017
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The Australian Therapeutic Goods Administration suspended several medical devices from the Australian Register of Therapeutic Goods.

SerenoCem Granules BCG050, manufactured by Endotherapeutics, was suspended Aug. 31, and Thermo Fisher Scientific Australia’s QuickVue One-Step hCG urine test kit on Sept. 6.

Other devices suspended in 2017 include cardiopulmonary bypass system heater-cooler units from two manufacturers — Australian Blood Management Unit Trust and Lovell Surgical Supplies.

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