Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Unique Device Identifier IF0950: 20816101020045, lot numbers 30244, 30928, 31288, 31642, 32331, 32562, 32850
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Focus Diagnostics Inc
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Product Codes/Lot Numbers:
Unique Device Identifier IF0950: 20816101020045, lot numbers 30244, 30928, 31288, 31642, 32331, 32562, 32850
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1685-2017
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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.
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