FDA Issues Class l Recall of Three Blood Test Analyzers

Marcia Frellick

May 23, 2019

The US Food and Drug Administration (FDA) today announced a Class 1 recall of Beckman Coulter DxH 800, DxH 600, and DxH 900 hematology analyzers after complaints of inaccurate platelet counts.

The devices help diagnose diseases and conditions such as anemia, clotting disorders, blood cancers, immune system disorders, and infections.

This updates an urgent medical device correction letter first issued by Beckman Coulter in 2018, after the company received complaints of inaccurate blood platelet counts, the FDA said in a news release. More than 2000 labs in the US may be affected by this recall, the FDA warns.

"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, in the 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."

Stenzel added, "Because this may cause 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. We are working with the manufacturer to correct the problem with the devices as quickly as possible and will continue to communicate as more information becomes available."

The FDA also recommends that laboratories use backup analyzers, if available, to confirm platelet results and advises they should follow instructions in the Urgent Medical Device Correction letter sent out earlier this week by Beckman Coulter before reporting platelet counts outside the lab.

The agency encourages laboratories to contact any potentially affected physicians to discuss whether retesting of patients who were recently tested is appropriate.

According to the FDA, Beckman Coulter has not received complaints that other reported counts, including white blood cell count, white blood cell differential, red blood count, or hemoglobin tests are compromised.

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