Health

FDA: Beware of Faulty Platelet Counts From B-C Analyzers

WASHINGTON — The FDA alerted hospitals and clinical labs Thursday that a Class I recall has been declared for certain Beckman Coulter blood analyzers because they may provide inaccurate platelet counts.

“[W]e 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,” 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. “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 units involved are Beckman Coulter’s DxH 600, DxH 800, and DxH 900 analyzers. “The FDA is aware of more than 2,000 laboratories in the U.S. that may be affected, in locations such as large medical centers and small community hospitals,” the agency said.

According to the FDA‘s announcement, the company originally notified customers last August of a potential problem with “erroneously elevated platelet results.” Such a problem could mean that a platelet deficiency goes undetected. The FDA said it couldn’t estimate how many patients may have been affected, although it has not yet received any reports of serious adverse events stemming from the defect.

Labs using the affected devices are instructed to “use backup analyzers, if available, to confirm platelet results or perform manual platelet estimate/screening and follow the instructions in the Urgent Medical Device Correction letter dated May 20, 2019 before reporting platelet counts out of the laboratory,” according to the FDA‘s alert.

2019-05-23T15:45:00-0400


Source link
Tags
Back to top button
close
Thanks !

Thanks for sharing this, you are awesome !

Pin It on Pinterest

Share This

Share this post with your friends!