Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
FDA Recall Z-1686-2017 · Posted 2017-03-27
Recalling FirmFocus Diagnostics Inc
Recall StatusTerminated
Product CodeLHL
Date Initiated2017-02-15
Date Terminated2017-04-13
Product Quantity1,400 units
Reason for Recall
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.
Firm Action
Focus Diagnostics/DiaSorin Molecular is issuing a medical device correction for the Legionella IFA (Immuno Fluoresence Assay). On February 1, 2017, the firm was notified that the Legionella IFA was not properly classified according to 21 CFR Part 807. The product is being withdrawn from the market. Use of the product should be immediately discontinued, and any remaining inventory should be immediately destroyed. The firm sent notice to its consignees, which should be reviewed with the facility's laboratory or mediclal director. Patient results obtained with all lots of the affected product should be evaluated by the clinician and if recommended, retested by another method.
Root Cause
No Marketing Application
Distribution Pattern
Product was distributed to three testing laboratories in California, New Jersey and Virginia
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.