FDA alerts hospitals, laboratories and health care professionals about recall of Beckman Coulter blood test analyzers due to risk of inaccurate platelet analyzing results

FDA alerts hospitals, laboratories and health care professionals about recall of Beckman Coulter blood test analyzers due to risk of inaccurate platelet analyzing results

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.  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 in blood) levels in ...

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