Focus Diagnostics Inc Recall: Legionella IFA Substrate Slide (IF0951) intended for qualita
Focus Diagnostics Inc Recall: Legionella IFA Substrate Slide (IF0951) intended for qualita is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Focus Diagnostics Inc; Product: Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum anti
| Recalling firm | Focus Diagnostics Inc |
|---|---|
| Product | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Product was distributed to three testing laboratories in California, New Jersey and Virginia |
| Recall initiated | 20170215 |
| Recall number | Z-1686-2017 |
| Category | device |
| State | CA |
| Country | United States |
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