Devices

Device Recall UniCel Closed Tube Aliquotter for UniCel DxC 660i, 680i, 860i and 880i Synchron Access Clinical Sys

Model / Serial
Serial Numbers: 547-574 (UCTA)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution and US (nationwide) and the countries of China, France, Italy and Taiwan.
Product Description
Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. || Product Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in-vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Device Recall UniCel Closed Tube Aliquotter for UniCel DxC 660i, 680i, 860i and 880i Synchron Access Clinical Sys

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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