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Medical Devices / Regulatory Affairs

FDA Issues Alert for Beckman Coulter Blood Analyzers

May 29, 2019
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The FDA issued an alert over a recall of Beckman Coulter DxH 800, DxH 600 and DxH 900 blood analyzers, updating an urgent medical device correction letter the company issued following complaints of inaccurate blood platelet counts.

“Inaccurate platelet counts may create serious health risks for patients,” said Tim Stenzel, director of CDRH’s Office of In Vitro Diagnostics and Radiological Health. The agency is 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.”

The company said that a software update may alert laboratory personnel to inaccurate results. But the FDA has not evaluated the software and is working with the company to determine if the software update can resolve the matter.

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