Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human Recalled by Focus Diagnostics Inc Due to After a submission for CLIA database update from...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Focus Diagnostics Inc directly.
Affected Products
Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Quantity: 196 units
Why Was This Recalled?
After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.
Where Was This Sold?
Product was distributed to three testing laboratories in California, New Jersey and Virginia
About Focus Diagnostics Inc
Focus Diagnostics Inc has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report