Devices

Device Recall UniCel CxH800 Coulter Cellular Analysis System

Model / Serial
All Serial Numbers are affected.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Class 2 Recall - Worldwide Distribution -- USA, and the countries of : Canada, Australia, Macao, Belgium, Malaysia, Colombia, Myanmar, Croatia, Netherlands, Czech Republic, Norway, France, Philippines, Germany, Puerto Rico, Greece, Qatar,Hong Kong, Russian Federation, Hungary, Saudi Arabia, India, Singapore, Spain, Israel, taly Sweden, Japan, Switzerland, Korea, Turkey and United Kingdom.
Product Description
UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. || The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Device Recall UniCel CxH800 Coulter Cellular Analysis System

Manufacturer

Beckman Coulter Inc.

Manufacturer Address
Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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