Devices

Device Recall UniCel DxI 800 Access Immunoassay Systems

Model / Serial
DxI System Software versions: 2.3, 2.4, 4.1, 4.2.1, 4.3 (Current released version), 4.3.2 (Released to a single Japanese customer only)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Liechtenstein, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
Product Description
UniCel DxI 800 Access Immunoassay || Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanufactured || A25288, DxI 800 with spot B A71456, DxI 800 || Reconditioned A25285 || The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Device Recall UniCel DxI 800 Access Immunoassay Systems

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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