DiaSorin Molecular LLC
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 13
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2153-2023 | Class II | Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, | June 14, 2023 |
| Z-1209-2023 | Class II | Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay de | January 30, 2023 |
| Z-1210-2023 | Class II | Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previo | January 30, 2023 |
| Z-0457-2022 | Class II | Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 | November 19, 2021 |
| Z-0162-2022 | Class II | SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051 | September 23, 2021 |
| Z-2547-2020 | Class II | MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: i | May 12, 2020 |
| Z-2548-2020 | Class II | MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for t | May 12, 2020 |
| Z-2549-2020 | Class II | MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument | May 12, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251978 | LIAISON NES FLU A/B, RSV & COVID-19 | December 23, 2025 |
| K252387 | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Contr | October 30, 2025 |
| DEN230092 | Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit | July 15, 2024 |
| K220963 | Simplexa COVID-19 & Flu A/B Direct | March 17, 2023 |
| K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack | November 5, 2022 |
| K212147 | Simplexa COVID-19 Direct | September 13, 2022 |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | August 22, 2020 |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | November 26, 2019 |
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | May 13, 2019 |
| K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | December 19, 2018 |
| K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack | November 7, 2018 |
| K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | August 13, 2018 |
| K173798 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | March 14, 2018 |