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Sign in to claim this brandDiaSorin Molecular LLC
US
Last updated September 17, 2026
About
Diasorin is the global leader in Molecular Diagnostics and Immunodiagnostics market. Discover all Diasorin’s diagnostic solutions.
From the manufacturer's own website. Source
What DiaSorin Molecular LLC makes
DiaSorin Molecular LLC manufactures laboratory-based diagnostic devices, including thermal cyclers for nucleic acid amplification, assay development reagents, and microplates for immunoassays. Their product line includes nucleic acid test kits for detecting *Clostridium difficile*, respiratory viruses, and *Candida auris*, as well as antibody tests for *West Nile virus* (IgM) and *Herpes simplex virus* (HSV-1 & 2, IgG) via immunoblot and ELISA formats. Additional offerings include pre-developed primer pairs and controls for viral assays, such as *Varicella-zoster virus* (VZV) and *measles*.
The company’s devices are regulated under FDA pathways, including 510(k) clearances and De Novo authorisations, spanning Class I and Class II classifications. Products are listed in the FDA’s 510(k) and UDI registries. DiaSorin Molecular LLC operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- 11331 Valley View St, CYPRESS, CA, 90630
- Website
- molecular.diasorin.com
- it.linkedin.com/company/diasorin
- facebook.com/diasorin
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2023365
- DUNS Number
- —
Catalogue (108)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | K173498 | FDA 510(k) | Class II | Active |
| Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | K183223 | FDA 510(k) | Class II | Active |
| Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | K201505 | FDA 510(k) | Class II | Active |
| Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) | K252387 | FDA 510(k) | Class II | Active |
| Liaison Nes Flu A/B, Rsv & Covid-19 | K251978 | FDA 510(k) | Class II | Active |
| Simplexa COVID-19 & Flu A/B Direct | K220963 | FDA 510(k) | Class II | Active |
| Simplexa COVID-19 Direct | K212147 | FDA 510(k) | Class II | Active |
| Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) | DEN230092 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (8)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
DiaSorin Molecular LLC has initiated eight recall records between May 12, 2020, and June 14, 2023, involving products used with COVID-19, Flu A/B, and RSV assays. The records include open, classified, and terminated statuses, with reasons citing potential leakage or contamination risks from reusable discs, software malfunctions leading to false negatives, and unapproved raw materials affecting amplification signals. Additional concerns involve disc malfunctions causing liquid spillage and cross-contamination in laboratory settings.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 14, 2023 | Z-2153-2023 | — | open, classified | There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc. |
| Jan 30, 2023 | Z-1210-2023 | — | open, classified | Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes. |
| Jan 30, 2023 | Z-1209-2023 | — | open, classified | Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes. |
| Nov 19, 2021 | Z-0457-2022 | — | open, classified | A subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV Direct Gen II. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned. |
| Sep 23, 2021 | Z-0162-2022 | — | open, classified | Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals. |
| May 12, 2020 | Z-2547-2020 | — | terminated | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. |
| May 12, 2020 | Z-2549-2020 | — | terminated | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. |
| May 12, 2020 | Z-2548-2020 | — | terminated | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. |