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# Safety Alert on Beckman Coulter Hematology Analyzers
- URL: https://www.fdaweb.com/safety-alert-on-beckman-coulter-hematology-analyzers/
- Published: 2019-05-23T12:00:00.000Z
- Updated: 2026-09-15T01:28:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144183

FDA has issued a [safety alert](https://www.fda.gov/medical-devices/medical-device-recalls/beckman-coulter-life-sciences-recalls-dxh800-and-dxh600-and-dxh-900-hematology-analyzers-due-risk?ref=fdaweb.com) on a Class 1 recall of Beckman Coulter’s DxH 800, DxH 600 and DxH 900 hematology analyzers, which perform blood tests to diagnose diseases and conditions such as anemia, infections, blood clotting problems, blood cancers and immune system disorders. The agency says the alert is an update to an urgent medical device correction letter first issued by the company in 2018, after it received inaccurate blood platelet count complaints.

The recall is related to the devices’ platelet analyzing function, according to FDA. “Beckman Coulter has not received complaints that this issue impacts other reported parameters, including white blood cell count, white blood cell differential, red blood count or hemoglobin tests,” it says. “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.”