Diasorin Molecular, LLC

• QOF — Microbiology3 devices
• OZZ — Microbiology2 devices
• PGI — Microbiology2 devices
• NJR — Microbiology1 device
• OCC — Microbiology1 device
• PGX — Microbiology1 device
• PLO — Microbiology1 device
• QDZ — Microbiology1 device
• QQX — Microbiology1 device
• SBT — Microbiology1 device

• Z-2153-2023 — Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452Class II·Ongoing·2023-06-14
• Z-1210-2023 — Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.Class II·Ongoing·2023-01-30
• Z-1209-2023 — Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2Class II·Ongoing·2023-01-30
• Z-0457-2022 — Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455Class II·Ongoing·2021-11-19
• Z-0162-2022 — SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051Class II·Ongoing·2021-09-23
• Z-2549-2020 — MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA present in cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of VZV infection.Class II·Terminated·2020-05-12
• Z-2547-2020 — MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with signs and symptoms of HSV-1 or HSV-2 infection of the central nervous system (CNS) or cutaneous and mucocutaneous lesions.Class II·Terminated·2020-05-12
• Z-2548-2020 — MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and symptoms of VZV infections of the central nervous system (CNS).Class II·Terminated·2020-05-12

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K260333 — LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitCode PGX·2026-06-15
• K251978 — LIAISON NES FLU A/B, RSV & COVID-19Code QOF·2025-12-23
• K252387 — Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)Code QOF·2025-10-30
• DEN230092 — Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)Code SBT·2024-07-15
• K220963 — Simplexa COVID-19 & Flu A/B DirectCode QOF·2023-03-17
• K202755 — Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackCode QDZ·2022-11-05
• K212147 — Simplexa COVID-19 DirectCode QQX·2022-09-13
• K201505 — Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control PackCode OCC·2020-08-22
• K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackCode PGI·2019-11-26
• K190219 — Simplexa VZV Direct, Simplexa VZV Positive Control PackCode PLO·2019-05-13
• K183223 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackCode OZZ·2018-12-19
• K182467 — Simplexa GBS Direct, Simplexa GBS Positive Control PackCode NJR·2018-11-07
• K173498 — Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackCode OZZ·2018-08-13
• K173798 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackCode PGI·2018-03-14