Recall Z-1686-2017 ยท LHL Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
Focus Diagnostics Inc
Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
| Date | Mar 27, 2017 (initiated Feb 15, 2017) |
| Status | Terminated |
| 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. |
| Root cause | No Marketing Application |
| Action | Focus Diagnostics/DiaSorin Molecular is issuing a medical device correction for the Legionella IFA (Immuno Fluoresence Assay). On February 1, 2017, the firm was notified that the Legionella IFA was not properly classified according to 21 CFR Part 807. The product is being withdrawn from the market. Use of the product should be immediately discontinued, and any remaining inventory should be immediately destroyed. The firm sent notice to its consignees, which should be reviewed with the facility's laboratory or mediclal director. Patient results obtained with all lots of the affected produc |
| Quantity | 1,400 units |
| Distribution | Product was distributed to three testing laboratories in California, New Jersey and Virginia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.