Devices

VITROS Signal Reagent

Model / Serial
Product Description
in-vitro_medical_device
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of VITROS Signal Reagent

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
LAANSM

One device with a similar name

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Device Recall VITROS Signal Reagent

Model / Serial
Lots 8530 distributed to US customers and 1 Canadian customer (NOTE: Lot 8350 was distributed from Wales facility to non-US foreign customers.)
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Medical facilities nationwide and 1 foreign affiliate in Canada.
Product Description
VITROS Immunodiagnostic Products Signal Reagent, Catalog No. 107 2693 --- an in vitro diagnostic for use on the VITROS Immunodiagnostics ECi/ECiQ System, which is used to screen and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B, or C), thyroid disorders, HIV, and pregnancy.
Manufacturer
Ortho-Clinical Diagnostics

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Disclaimer

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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