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Focus Diagnostics Inc recalls Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodie
Recalled April 5, 2017 · FDA recall Z-1686-2017 · 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
1,400 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 Substrate Slide (IF0951) 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 →