FDA alerts hospitals | 合法醫療器材資訊網
![FDA alerts hospitals](https://i.imgur.com/6y29Lx7.jpg)
2019年5月23日—Therecallisrelatedtothedevices'plateletanalyzingfunction.BeckmanCoulterhasnotreceivedcomplaintsthatthisissueimpactsother ...
![FDA alerts hospitals](https://i.imgur.com/6y29Lx7.jpg)
The U.S. Food and Drug Administration is alerting[1] hospitals, laboratories and providers of a Class 1 recall of Beckman Coulter DxH 800, DxH 600 and DxH 900 hematology analyzers—devices that run blood tests to help providers diagnose diseases and conditions such as anemia (low red blood cell or hemoglobin count), infections, blood clotting problems, blood cancers and immune system disorders. This is an update to an urgent medical device correction letter first issued by the company in 2018, after the company received complaints of inaccurate blood platelet counts.
Hematology analyzers run diagnostic tests that count the number of different types of red and white blood cells, platelets, hemoglobin (oxygen levels) and hematocrit (volume of red blood cells...
510(k) Premarket Notification | 合法醫療器材資訊網
510(k) Substantial Equivalence Determination Decision ... | 合法醫療器材資訊網
Beckman Coulter Life Sciences Recalls DxH800 and DxH600 ... | 合法醫療器材資訊網
Beckman Coulter's Automated Blood Banking Analyzer ... | 合法醫療器材資訊網
Beckman Coulter's SARS | 合法醫療器材資訊網
Establishment Registration & Device Listing | 合法醫療器材資訊網
FDA alerts hospitals | 合法醫療器材資訊網
Premarket Approval (PMA) | 合法醫療器材資訊網
![](https://i.imgur.com/6y29Lx7.jpg)
【貝克曼庫爾特Unicel DxH800庫爾特血液分析系統】許可證字號:衛署醫器輸字第021536號
器材品名:貝克曼庫爾特UnicelDxH800庫爾特血液分析系統許可證字號:衛署醫器輸字第021536號註銷狀態:已註銷註銷日期:2018/08/...
![](https://i.imgur.com/6y29Lx7.jpg)
【貝克曼庫爾特血液分析系統】許可證字號:衛署醫器輸字第025087號
器材品名:貝克曼庫爾特血液分析系統許可證字號:衛署醫器輸字第025087號註銷狀態:註銷日期:註銷理由:有效日期:2023/07/16發證...
![](https://i.imgur.com/6y29Lx7.jpg)
【貝克曼庫爾特艾科爾斯流式細胞儀】許可證字號:衛部醫器輸字第028078號
器材品名:貝克曼庫爾特艾科爾斯流式細胞儀許可證字號:衛部醫器輸字第028078號註銷狀態:註銷日期:註銷理由:有效日期:2026/01/...
![](https://i.imgur.com/6y29Lx7.jpg)
【貝克曼庫爾特血液分析系統】許可證字號:衛部醫器輸字第031441號
器材品名:貝克曼庫爾特血液分析系統許可證字號:衛部醫器輸字第031441號註銷狀態:註銷日期:註銷理由:有效日期:2023/08/30發證...