Devices

Device Recall Access Immunoassay Systems Hybritech free PSA Calibrator

Model / Serial
Part Number: 37215, Lot Number: 715293.
Product Classification
Immunology and Microbiology Devices
Device Class
3
Implanted device?
No
Distribution
Nationwide Distribution -- OH, CA, TX, OR, MD, MO, FL and PA.
Product Description
Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. || The Access Hybritech free PSA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (PSA) in human serum using the Access Immunoassay System.
Manufacturer
Beckman Coulter Inc
1 Event
- Recall of Device Recall Access Immunoassay Systems Hybritech free PSA Calibrator

Manufacturer

Beckman Coulter Inc

Manufacturer Address
Beckman Coulter Inc, 200 S Kraemer Blvd, Brea CA 92822-6208
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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