FDAFebruary 15, 2017device
Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
focus diagnosticsfocus
UPCs
20816101020045
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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