Devices

Device Recall OptiView Amplification Kit (250 Test)

Model / Serial
UDI 04015630984749, Lot Numbers: Y19318
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,
Product Description
OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic
Manufacturer
Ventana Medical Systems Inc
1 Event
- Recall of Device Recall OptiView Amplification Kit (250 Test)

Manufacturer

Ventana Medical Systems Inc

Manufacturer Address
Ventana Medical Systems Inc, 1910 E Innovation Park Dr, Oro Valley AZ 85755-1962
Manufacturer Parent Company (2017)
Roche Holding Ag
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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