Devices

Device Recall Sex Hormone Binding Blobulin (SHBG) Reagent

Model / Serial
Lot Numbers:009046, 010202, 829586, 909837, 914557, 915628, 917613, 919184
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA including AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NV, NY, OH, OK, OR, TN, TX, UT, VA, WA, AND WI and the country of Canada
Product Description
Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617 || The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Device Recall Sex Hormone Binding Blobulin (SHBG) Reagent

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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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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