Devices

Device Recall ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM 33340, 33345

Model / Serial
Lot Numbers: 716707, 720541, 720542, 721451, 721452, 722677, 722678, 821024, 821025, 821515, 821663, 823314, 823523, 823524, 823850, 825783, 825784, 826258, 826259, 827876, 828479, 829974, 831218, 850000, 850003, 850004, 850005, 850010, 850011, 850013, 908322, 908323, 908917, 908918, 909803, 909804, 911338, 911339, 911748, 912628, 912629, 913131, 913132, 913265, 913274, 913500, 913821, 914632, 915132, 915417, 915670, 915850, 916720, 916721, 916721A, 917611, 918460 Note: These Lot Numbers represent all reagent lots released to field that could be used in conjunction with Unicel DxI Access Immunoassay Systems.
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA and Canada
Product Description
Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl Access Immunoassay Systems; Reagent Part Numbers: A78803 & 33340; Calibrator Part Number: 33345 || The intended use: The Access AccuTnI assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac Troponin I determination also aids in the risk stratification of patients with unstable angina or non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.
Manufacturer
Beckman Coulter Inc.
1 Event
- Recall of Device Recall ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM 33340, 33345

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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