Devices

Device Recall VITROS Immunodiagnostic Products TSH Reagent Pack

Model / Serial
Lot 5040 (Expiry date 19 Dec 2016)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US to VA, WV, GA, TN, KY, MN, SD, AR, OK and Internationally to Canada
Product Description
VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique Device Identifier No. 10758750000227, IVD --- Ortho-Clinical Diagnostics Pencoed Bridgend CF35 5PZ UK || For the in vitro quantitative measurement of thyroid stimulating hormone (TSH) 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 TSH 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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