10月5日,美国食品药品监督管理局(FDA)发布通知称,澳大利亚埃卢姆公司出售给美国的部分家用新冠检测盒可能出现“虚假阳性结果”。 FDA要求使用了埃卢姆检测盒检测出阳性结果的人尽快联系医生复查,并敦促购买了质量问题检测盒的人们进行更换。People who used an Ellume kit and received a positive result were instructed to contact their healthcare provider for a follow-up. Everyone who owns a kit is urged to check the Ellume-provided list of problematic lots, sent out between April and August this year, and request a replacement after submitting receipts. 作为首个可以完全在家进行的非处方新冠病毒检测工具,埃卢姆公司在去年12月获得FDA紧急使用授权后,已经向美国运送了大约350万个新冠检测盒。Ellume has shipped approximately 3.5 million
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