Food and Drug Administration (FDA) Hematology Analyzer Device Recall Announcement

Wisconsin Department of Health Services sent this bulletin at 05/29/2019 01:54 PM CDT
DHS Logo Original 07/11/2018

Division of Quality Assurance: Notifications & Updates

Attn: All Wisconsin Clinical Laboratories

Food and Drug Administration (FDA) Hematology Analyzer Device Recall Announcement

Beckman Coulter is recalling the DxH 800, DxH 600, and DxH 900 Hematology Analyzers due to risk of inaccurate results. The FDA has identified this as a Class I recall, the most serious type of recall and have warned that the “use of these devices may cause serious injuries or death.”

Complete details and corrective action to address the device recall can be found on the FDA medical device recall page.