Devices

Access/DxI Immunoassay System

Model / Serial
All versions are affected.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Nationwide Distribution & Canada
Product Description
Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N; || Synchron LXi 725; UniCel DxI 800 Access Immunoassay Systems, Part Number: 973100; UniCel DxI 600 Access Immunoassay Systems, Part Number A30260; || UniCel DxC 600i, Part Number: A25656; UniCel DxC 660i, Part Number: A64871; UniCel DxC 860i, Part Number: A64935; UniCel DxC 880i, Part Number: A59102; SYNCHRON Access Clinical || Systems || The Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids. Function of the Peristaltic Pump: to aspirate unbound material from reaction vessels and to move waste from vacuum jar into waste bottle through associated tubing within the Access Immunoassay System.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Access/DxI Immunoassay System

Manufacturer

Beckman Coulter Inc.

Manufacturer Address
Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
Manufacturer Parent Company (2017)
Danaher Corporation
Source
USFDA

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