Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Hematology Analyzers
Beckman Coulter is recalling 1,025 UniCel DxH 800 and DxH 600 hematology analyzers because specific check valves may fail, potentially causing air or liquid leaks.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure (leak) in a medical device used for patient diagnostics, which poses a risk of harm but has no reported injuries or fatalities in the source text.
Plain-English summary
Beckman Coulter Inc. is recalling 1,025 units of the UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. These are automated hematology analyzers used in clinical laboratories for in vitro diagnostic screening of patient populations. The recall covers units distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations.
The recall was initiated because the company's internal investigation indicates that specific lots of check valves used in several locations within the systems may fail. A failure of these valves may result in an air or liquid leak at the VCS Waste Chamber. The affected units are identified by specific part numbers (629029 for DxH 800 and B23858 for DxH 600) and a list of serial numbers provided in the official recall notice.
Clinical laboratories and other users of these devices should check their inventory against the provided serial numbers to determine if their units are affected. Users should contact Beckman Coulter for instructions on how to proceed with the recall and any necessary remediation.
The recalled product
- Product
- UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is availa
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- Affected units
- 1,025
Distribution
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