Devices

Device Recall VITROS Immunodiagnostic Products Signal Reagent

Model / Serial
Lot 3082, expiry date 7/27/2015
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution.
Product Description
VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.
Manufacturer
ORTHO-CLINICAL DIAGNOSTICS
1 Event
- Recall of Device Recall VITROS Immunodiagnostic Products Signal Reagent

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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