DiaSorin Molecular LLC
6 FDA 510(k) clearances · Recalling firm
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| Record | Firm | Date |
|---|---|---|
| Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Dis recall (Z-2153-2023) | DiaSorin Molecular LLC | 2023-07-18 |
| Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previou recall (Z-1209-2023) | DiaSorin Molecular LLC | 2023-03-03 |
| Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; w recall (Z-1210-2023) | DiaSorin Molecular LLC | 2023-03-03 |
| MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Produc recall (Z-2547-2020) | DiaSorin Molecular LLC | 2020-07-10 |
| MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instru recall (Z-2548-2020) | DiaSorin Molecular LLC | 2020-07-10 |
| MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX i recall (Z-2549-2020) | DiaSorin Molecular LLC | 2020-07-10 |
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Every clearance here is in the API, with alerts when new ones post.