FDA alerts hospitals, laboratories and health care professionals about rec ...



The U.S. Food and Drug Administration is alerting 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.

Product:
Hematology analyzersBeckman CoulterMedical Devices
Units Affected:    0
Recall Date:    May 23, 2019
Mfg:
Beckman Coulter
Last Published:    May 23, 2019
Official Site:    Link

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Emert Number:    #-10144995806
Emert Status:    Announced