FDA Alerts Hospitals, Labs, Others About Recall of Beckman Coulter Blood Test Analyzers

   By Stephen Nakrosis

The U.S. Food and Drug Administration said Thursday it is alerting hospitals, laboratories and providers about an earlier recall of some blood diagnostics devices sold by Beckman Coulter, a manufacturer of medical diagnostics products.

The FDA said the Class 1 recall covers Beckman Coulter DxH 800, DxH 600 and DxH 900 hematology analyzers.

The recall relates to the devices' platelet analyzing function, the FDA said, adding the company hasn't received complaints about other of these devices' functions.

The FDA said its latest action is an update to an urgent medical device correction letter first issued by Beckman Coulter in 2018. Beckman Coulter notified its customers in August of that year they had been informed of erroneously elevated platelet results that were occurring without error messages, the FDA said.

The FDA said Beckman Coulter has indicated to customers a software update to the device may serve to alert laboratory personnel to any inaccurate results, but the agency hasn't evaluated the software. It is currently working with the company to determine if the software update alone is adequate to address the recall.

The FDA said it is aware of more than 2,000 laboratories in the U.S. that may be affected.

Danaher Corp. (DHR) is the parent organization of Beckman Coulter.

Beckman Coulter didn't immediately respond to a request for comment.

--Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

May 23, 2019 14:24 ET (18:24 GMT)

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