Recall Z-1686-2017— Focus Diagnostics Inc
Class II · Terminated
Class II FDA medical device recall by Focus Diagnostics Inc, initiated 2017-02-15, terminated 2017-04-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.. 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..
- Recalling firm
- Focus Diagnostics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-15
- Terminated
- 2017-04-13
- Firm location
- Cypress, CA, United States
Product description
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.