Devices

Device Recall Ultrasonic Transducer Kits

Model / Serial
Access 2 Immunoassay Systems, Catalog Number: 81600N. UniCel DxI 600 Access Immunoassay Systems, Catalog Numbers: A30260 and A71460. UniCel DxI 800 Access Immunoassay Systems, Catalog Numbers: 973100 and A71456. UniCel DxC 600i SYNCHRON Access Clinical Systems, Catalog Number: A25640. Catalog numbers for these systems are included in the respective DxI 600 and DxI 800 model numbers: UniCel DxC 660i SYNCHRON Access Clinical Systems, UniCel DxC 680i SYNCHRON Access Clinical Systems, UniCel DxC 860i SYNCHRON Access Clinical Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution and USA Nationwide - and the countries of Australia, Canada, China, France, Hong Kong, Italy, Japan, Mexico, Portugal, Spain, Switzerland, Taiwan,and Turkey.
Product Description
Ultrasonic Transducer Kits || For use with the Access Family of Immunoassay Systems*. || *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, || UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i || systems.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Device Recall Ultrasonic Transducer Kits

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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