Recall Z-1686-2017 — Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
U.S. FDA — Device Enforcement · United States · 2017-02-15 · Class II
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Reported risk: 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.
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