Devices

Device Recall Simplexa Flu A/B and; RSV Direct assay

Model / Serial
Model Number MOL2650. Lot Numbers: 24493, 24495, 24535, 24536, 24591, 24603, 24605, 24732, 24773, 24788, 24797, 24807.
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution: US (nationwide) and to countries of:Canada, Sweden, Belgium, Spain, Portugal, Slovenia, and Israel.
Product Description
Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650.
Manufacturer
Focus Diagnostics Inc
1 Event
- Recall of Device Recall Simplexa Flu A/B and; RSV Direct assay

Manufacturer

Focus Diagnostics Inc

Manufacturer Address
Focus Diagnostics Inc, 11331 Valley View St, Cypress CA 90630-5366
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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