Over 2,000 U.S. laboratories ranging from small hospitals to large medical centers have been affected and notified by the U.S. Food and Drug Administration that the Beckman Coulter DxH 800, DxH 600 and DxH 900 hematology analyzer are now under a Class 1 recall.
The recall comes after the F.D.A. found numerous inaccurate platelet analyzing results. Platelet is pivotal because it allows the blood to clot in the body.
“An inaccurate result may lead a provider to conclude a patient is suitable for surgery, when they may not be,” said Tim Stenzel, director of the office of in-vitro diagnostics and radiological health in the FDA's Center for Devices and Radiological Health.
“Inaccurate platelet counts may create serious injury, or even death, to a patient, we are urging health care professionals to be aware of the potential for inaccurate diagnostic results with these analyzers and to take appropriate actions including the use of alternative diagnostic testing or confirming analyzer results with manual scanning or estimate of platelets.”
