Legionella IFA — Class II medical device recall Z-1685-2017
Terminated recall by Focus Diagnostics Inc, reported 2017-04-05, distributed in CA, NJ, VA. After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found tha
| Recall number | Z-1685-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Focus Diagnostics Inc, Cypress, CA, United States |
| Recall initiated | 2017-02-15 |
| Classified | 2017-03-27 |
| Reported by FDA | 2017-04-05 |
| Terminated | 2017-04-13 |
| Distributed | CA, NJ, VA |
| Quantity | 196 units |
| UPC / GTIN / UDI-DI | 20816101020045 |
| Lot numbers | 30244, 30928, 31288, 31642, 32331, 32562, 32850 |
Product
Legionella IFA (IF0950) 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1685-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.