Chrysalis Intelligence · Sponsors · Diasorin Molecular, LLC

Diasorin Molecular, LLC

Cypress, CA, US · 8 510(k) clearances · 8 recalls

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Total clearances
8
2020-08-22 → 2026-06-15
Last 12 months
3
Product codes
6
Most recent
2026-06-15
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Class II Microbiology 3 2025-12-23
PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System Class II Microbiology 1 2026-06-15
SBT Device To Detect Microbial Colonization Directly From Clinical Specimens. Class II Microbiology 1 2024-07-15
QDZ Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection Class II Microbiology 1 2022-11-05
QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test Class II Microbiology 1 2022-09-13
OCC Respiratory Virus Panel Nucleic Acid Assay System Class II Microbiology 1 2020-08-22
Safety

Recalls (8)

Class I (serious)
0
Risk of injury / death
Total recalls
8
Currently ongoing
5
Most recent
2023-06-14
DateSeverityStatusRecall # ProductCodeReason
2023-06-14 Class II Ongoing Z-2153-2023 Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 bo… — There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc.
2023-01-30 Class II Ongoing Z-1210-2023 Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition … — Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error code…
2023-01-30 Class II Ongoing Z-1209-2023 Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2 — Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error code…
2021-11-19 Class II Ongoing Z-0457-2022 Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455 — 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. …
2021-09-23 Class II Ongoing Z-0162-2022 SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051 — Due to unapproved raw materials used in the manufacturing of Covid-19 control pack, their is the potential for delayed amplification signals.
2020-05-12 Class II Terminated Z-2549-2020 MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative … — Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
2020-05-12 Class II Terminated Z-2548-2020 MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detec… — Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
2020-05-12 Class II Terminated Z-2547-2020 MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use o… — Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2026-06-15 K260333 LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit PGX Class II Microbiology
2025-12-23 K251978 LIAISON NES FLU A/B, RSV & COVID-19 QOF Class II Microbiology
2025-10-30 K252387 Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) QOF Class II Microbiology
2024-07-15 DEN230092 Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) SBT Class II Microbiology
2023-03-17 K220963 Simplexa COVID-19 & Flu A/B Direct QOF Class II Microbiology
2022-11-05 K202755 Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack QDZ Class II Microbiology
2022-09-13 K212147 Simplexa COVID-19 Direct QQX Class II Microbiology
2020-08-22 K201505 Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack OCC Class II Microbiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence