Z-1686-2017 Class II Terminated
FDA device recall Z-1686-2017 was initiated by Focus Diagnostics Inc on February 15, 2017 and is designated Class II. 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. The recall status is terminated (terminated April 13, 2017). Affected quantity: 1,400 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2017
- Initiation Date
- February 15, 2017
- Termination Date
- April 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,400 units
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.
Distribution Pattern
Product was distributed to three testing laboratories in California, New Jersey and Virginia
Code Information
IF0951: 10816101020055, lot numbers 29428, 31871