Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of DiaSorinLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list DiaSorin Molecular LLC with 13 510(k) clearances and 8 device recalls. The most recent is a 510(k) clearance dated Jun 15, 2026: LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 15, 2026 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitK260333 · PGX | 510(k) clearances |
| Dec 23, 2025 | LIAISON NES FLU A/B, RSV & COVID-19K251978 · QOF | 510(k) clearances |
| Oct 30, 2025 | Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)K252387 · QOF | 510(k) clearances |
| Jul 15, 2024 | Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)DEN230092 · SBT | 510(k) clearances |
| Jun 14, 2023 | Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 DirecClass II · There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the d | Device recalls |
| Mar 17, 2023 | Simplexa COVID-19 & Flu A/B DirectK220963 · QOF | 510(k) clearances |
| Jan 30, 2023 | Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2Class II · Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contam | Device recalls |
| Jan 30, 2023 | Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.Class II · Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contam | Device recalls |
| Nov 5, 2022 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackK202755 · QDZ | 510(k) clearances |
| Sep 13, 2022 | Simplexa COVID-19 DirectK212147 · QQX | 510(k) clearances |
| Nov 19, 2021 | Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455Class II · A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/o | Device recalls |
| Sep 23, 2021 | SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051Class II · Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed | Device recalls |
| Aug 22, 2020 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control PackK201505 · OCC | 510(k) clearances |
| May 12, 2020 | MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicelClass II · Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negati | Device recalls |
| May 12, 2020 | MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX inClass II · Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negati | Device recalls |
| May 12, 2020 | MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoClass II · Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negati | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
