Focus Diagnostics Inc recalls Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodi…

Recall date

February 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1686-2017

FDA classification

Class II

Brand / firm

Focus Diagnostics Inc

Sold / distributed

Product was distributed to three testing laboratories in California, New Jersey and Virginia

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.