The FDA issued a Class I recall of three hematology analyzers – Beckman Coulter DxH 800, DxH 600, and DxH 900 – after reports of inaccurate platelet counts.
The devices are used in more than 2,000 labs around the U.S. The recall updates an urgent medical device correction letter that Beckman Coulter first issued in 2018, after it received complaints of inaccurate blood platelet counts.
“Inaccurate platelet counts may create serious health risks for patients,” said Tim Stenzel, MD, PhD, of the FDA’s Center for Devices and Radiological Health, in an agency press release. “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.”
The FDA recommends that laboratories use alternative diagnostic testing or, if possible, confirm platelet results with backup analyzers. It is unclear how many patient samples were affected; labs are being encouraged to contact physicians to discuss potential retesting of recently tested patients.
Beckman Coulter reports that other parameters, such as white blood cell count, white blood cell differential, red blood count, and hemoglobin tests, have not been affected.