Hematology analyzers help providers diagnose certain blood disorders and assess appropriate treatment options
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 a blood sample. These diagnostic tests are often performed as part of routine patient check-ups and are commonly used as part of pre-surgical laboratory patient assessments to help providers assess if patients are suitable and healthy for surgery. They are also used to determine whether a patient with a very low platelet count needs platelet transfusion or to evaluate for potential bleeding and bruising disorders. Platelets help blood to clot, so a patient with a very low platelet count (severe thrombocytopenia) may be at an increased risk for life-threatening bleeding. The recall is related to the devices' platelet analyzing function. Beckman Coulter has not received complaints that this issue impacts other reported parameters, including white blood cell count, white blood cell differential, red blood count or hemoglobin tests.
- From U.S. Food and Drug Administration Press Release. Photo courtesy of Beckman Coulter.