Devices

Device Recall VITROS Immunodiagnostic Products Total T4 Reagent Pack

Model / Serial
Lot Numbers:1836, 1840, 1845, 1850, 1860, 1870, 1880, 1890, 1900, 1910, 1920, 1930, 1940, 1950, 1968, 1978, 1988, 1998
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda
Product Description
VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical Diagnostics, || For in vitro diagnostic use only. For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.
Manufacturer
ORTHO-CLINICAL DIAGNOSTICS
1 Event
- Recall of Device Recall VITROS Immunodiagnostic Products Total T4 Reagent Pack

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS

Manufacturer Address
ORTHO-CLINICAL DIAGNOSTICS, FELINDRE MEADOWS, Bridgend United Kingdom
Manufacturer Parent Company (2017)
The Carlyle Group LP
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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