FDAFDA · Food and drugs·Recall number Z-1686-2017
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Published April 5, 2017 · Recall initiated: February 15, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Focus Diagnostics Inc
- Distributor
- Product was distributed to three testing laboratories in California, New Jersey and Virginia
- Lot
- IF0951: 10816101020055, lot numbers 29428, 31871
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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