openFDA 器械召回·· 6 天前精选AI 评分50
多款 hCG 快速检测产品因可能出现假阳性被召回
Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025; Henry Schein One Step+ hCG Combo test in Serum or Urine, Model/ Part: FHC-202/9004075; Alere hCG Combo Cassette (25mIU/mL) in Urine (CLIA Waived) or Serum, Model/ Part: FHC-202/92225; Pro Advantage By NDC Urine/Serum Pregnancy Cassette Device, Model/ Part: FHC-202/P080021
AI 导读
openFDA 器械召回信息显示，Fisher Scientific Sure-Vue、Beckman Coulter ICON 25、Henry Schein One Step+、Alere hCG Combo Cassette 及 Pro Advantage 等多款血清/尿液 hCG 快速检测产品被召回。
来源：openFDA 器械召回 · api.fda.gov