Devices

Device Recall Access Immunoassay Systems Estradiol

Model / Serial
Lot Numbers: 913016 (exp. 6/20/2010), 915171 (exp. 10/30/2010), 917766 (exp. 12/21/2010)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution: USA and Internationally to: Algeria, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, El Salvador, France, Georgia, Germany, Ghana, Greece, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Oman, Panama, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab, United Kingdom, Venezuela, Vietnam, and Zambia
Product Description
Access Immunoassay Systems Estradiol, Part Number: 33540 || Intended use: The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum and plasma using the Access Immunoassay systems.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Device Recall Access Immunoassay Systems Estradiol

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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