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FDA二级召回Beckman Coulter离心机SW40、SW41转子
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges...
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FDA对Beckman Coulter的Optima XE/XPN离心机SW40、SW41转子发起二级召回（召回事件编号99882）。转子存在不符合要求的显微组织，可能在使用中断裂。两条型号记录合并展示，召回编号和官方原文逐项保留。
同一召回 · 2 条型号记录
FDA召回事件编号：99882
| 产品 / 型号 | 召回编号 | 官方原文 |
|---|---|---|
| ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Optima XPN-80 (Model Numbers A99839 and A95765), Optima XE-100 (Model Numbers A99836 and A94516), and Optima XE-90 (Model Numbers A99833 and A94471) | Z-0201-2027 | 查看原文 |
| ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Optima XPN-80 (Model Numbers A99839 and A95765), Optima XE-100 (Model Numbers A99836 and A94516), and Optima XE-90 (Model Numbers A99833 and A94471) | Z-0202-2027 | 查看原文 |
推荐理由
FDA对Beckman Coulter Optima XE/XPN系列超速离心机SW40转子启动二级召回，涉及序列号范围与替换安排，实验室与质量负责人需核对在用设备。
来源：FDA Medical Device Recalls · accessdata.fda.gov