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Focus Diagnostics Inc recalls Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella
Recalled April 5, 2017 · FDA recall Z-1685-2017 · Focus Diagnostics
Hazard
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. · FDA Class II
Units
196 units
Sold at
Product was distributed to three testing laboratories in California, New Jersey and Virginia
Description
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.
Product
Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Manufacturer(s)
Focus Diagnostics Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →