Devices

Access Immunoassay Systems Estradiol

Model / Serial
33540 | 913016, 915171, 917766
Product Description
IVD: Oestradiol kit
Manufacturer
Beckman Coulter Inc.
1 Event
- Field Safety Notices about Access Immunoassay Systems Estradiol

Manufacturer

Beckman Coulter Inc.

Manufacturer Parent Company (2017)
Danaher Corporation
Source
SATP

2 devices with a similar name

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Access Immunoassay Systems Estradiol

Model / Serial
06656021190 (Estradiol III), 03000079190 (Estradiol II) | all
Product Description
IVD: Oestradiol kit
Manufacturer
Roche Diagnostics GmbH

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.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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