Devices

Device Recall Beckman Coulter UniCel Dxl 800 Access Immunoassay System

Model / Serial
Part Numbers: 386162 (software) 973100 (Instrument), Software Versions 2.2.1 and earlier.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
UniCel Dxl 800 Access Immunoassay System Software Versions 2.2.1 and earlier
Manufacturer
Beckman Coulter Inc
1 Event
- Recall of Device Recall Beckman Coulter UniCel Dxl 800 Access Immunoassay System

Manufacturer

Beckman Coulter Inc

Manufacturer Address
Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
Source
USFDA

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