Devices

Device Recall Access Thyroglobulin Assay

Model / Serial
Catalogue number: 33860 Lot numbers: 431990 434727 430969 522896 523251 Expiration date: 10/31/16 12/31/16 08/31/16 04/30/17 05/31/17
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Algeria, Australia, Austria, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Egypt, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Lebanon, Lithuania, Mexico, Morocco, New Zealand, Oman, Philippines, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam and Yemen.
Product Description
Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Device Recall Access Thyroglobulin Assay

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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