The FDA is warning hospitals, laboratories and clinicians about a Class 1 recall of three hematology analyzers manufactured by Beckman Coulter after several reports of inaccuracies related to blood platelet counts.
The recall affects three blood test analyzers, the Beckman Coulter DxH 800, DxH 600 and DxH 900. The analyzers help providers diagnose diseases and conditions like anemia, blood infections, blood-clotting problems, blood cancers and immune system disorders.
"Inaccurate platelet counts may create serious health risks for patients," said Tim Stenzel, MD,PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. "An inaccurate result may lead a provider to conclude a patient is suitable for surgery, when they may not be, to withhold platelet transfusion in patients who may need it, or to delay or miss the diagnosis of serious blood disorders. Because this may cause serious injury, or even death, to a patient, we are urging healthcare professionals to be aware of the potential for inaccurate diagnostic results."
Read the full FDA warning letter here.