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Recall Observatory FDA recall evidence

Device product

Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

Z-1685-2017

February 15, 2017

Class II

Product summary

Firm
Focus Diagnostics Inc
Event
Event 76619
Status
Terminated
Classification
Class II
Quantity
196 units
Official record key
device-enforcement:Z-1685-2017

Official wording

Reason: 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.

Code information: Unique Device Identifier IF0950: 20816101020045, lot numbers 30244, 30928, 31288, 31642, 32331, 32562, 32850

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.