Devices

Device Recall Legionella IFA Substrate Slide

Model / Serial
IF0951: 10816101020055, lot numbers 29428, 31871
Product Classification
Immunology and Microbiology Devices
Device Class
2
Implanted device?
No
Distribution
Product was distributed to three testing laboratories in California, New Jersey and Virginia
Product Description
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Manufacturer
Focus Diagnostics Inc
1 Event
- Recall of Device Recall Legionella IFA Substrate Slide

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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