DiaSorin Molecular LLC
Cypress, CA, US
DiaSorin Molecular LLC appears in FDA device records in Cypress, CA. FDA records list 32 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 20 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to DiaSorin Molecular LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Focus Diagnostics, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 32 510(k) clearances for DiaSorin Molecular LLC between 2007 and 2026. The busiest year on record is 2012, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 3 |
| 2008 | 2 |
| 2010 | 3 |
| 2012 | 4 |
| 2014 | 3 |
| 2015 | 3 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260333 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit | PGX | Substantially Equivalent | |
| K251978 | LIAISON NES FLU A/B, RSV & COVID-19 | QOF | Substantially Equivalent | |
| K252387 | Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) | QOF | Substantially Equivalent | |
| DEN230092 | Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) | SBT | Unknown | |
| K220963 | Simplexa COVID-19 & Flu A/B Direct | QOF | Substantially Equivalent | |
| K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack | QDZ | Substantially Equivalent | |
| K212147 | Simplexa COVID-19 Direct | QQX | Substantially Equivalent | |
| K201505 | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack | OCC | Substantially Equivalent | |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | PGI | Substantially Equivalent | |
| K190219 | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | PLO | Substantially Equivalent | |
| K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | OZZ | Substantially Equivalent | |
| K182467 | Simplexa GBS Direct, Simplexa GBS Positive Control Pack | NJR | Substantially Equivalent | |
| K173498 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | OZZ | Substantially Equivalent | |
| K173798 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | PGI | Substantially Equivalent | |
| K152408 | Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack | OCC | Substantially Equivalent | |
| K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | OQO | Substantially Equivalent | |
| K143651 | Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack | PGX | Substantially Equivalent | |
| K142365 | Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack | OCC | Substantially Equivalent | |
| K141458 | SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK | PGH | Substantially Equivalent | |
| DEN130049 | SIMPLEXA HSV 1&2 DIRECT | PGH | Unknown | |
| K120986 | STRATIFY JCV DXSELECT | OYP | Substantially Equivalent | |
| K120413 | SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK | OCC | Substantially Equivalent | |
| K113433 | SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT | OMN | Substantially Equivalent | |
| DEN120008 | STRATIFY JCV(TM) ANTIBODY | OYP | Unknown | |
| K102170 | SIMPLEXA FLU A/B & RSV | OCC | Substantially Equivalent | |
| K102314 | 3M INTEGRATED CYCLER (110V) & (220V) | OOI | Substantially Equivalent | |
| K100148 | SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 | OQW | Substantially Equivalent | |
| K073381 | PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M | LJN | Substantially Equivalent | |
| K073382 | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G | LSE | Substantially Equivalent | |
| K071511 | PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G | MXJ | Substantially Equivalent | |
| K071510 | HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950 | MXJ | Substantially Equivalent | |
| K062543 | HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G | MXJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2023365 | 2023365 | DiaSorin Molecular LLC | 11331 Valley View St, CYPRESS, CA 90630 US | 2026 | and 31 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OQW2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification
- OYPAnti-Jcv Antibody Detection Assay
- LJNAntibody Igm, If, Epstein-Barr Virus
- GOXAntigen, B. Pertussis
- GNQAntigen, Cf (Including Cf Control), Epstein-Barr Virus
- GQCAntisera, Cf, Equine Encephalitis Virus, Eee, Wee
- LKIAntisera, Fluorescent, Chlamydia Spp.
- GPJAntiserum, Fluorescent, Q Fever
- GPNAntiserum, Typhus Fever
- MYLAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
- MYMAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
- PMNAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
- OZZBordetella Pertussis Dna Assay System
- OMNC. Difficile Nucleic Acid Amplification Test Assay
- OZNC. Difficile Toxin Gene Amplification Assay
- MGMC. Trachomatis (Chlamydia Group)
- PABCytomegalovirus (Cmv) Dna Quantitative Assay
- OSUDengue Serological Reagents
- SBTDevice To Detect Microbial Colonization Directly From Clinical Specimens.
- LIBDevice, General Purpose, Microbiology, Diagnostic
- NOPElisa, Antibody, West Nile Virus
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- LSEEpstein-Barr Virus, Other
- PPMGeneral Purpose Reagent
- PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- OQOHerpes Simplex Virus Nucleic Acid Amplification Assay
- PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- PGHHsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
- OLDInternal Polymerase Chain Reaction Control, Not Assay Specific
- PLOMeningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
- OHQMulti-Analyte Controls Unassayed
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
- QLXNucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
- QDZQualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
- LSQReagent, Rickettsia Serological
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- MVUReagents, Specific, Analyte
- OOIReal Time Nucleic Acid Amplification System
- OTTResearch Use Only/Microbiology
- QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test
- OCCRespiratory Virus Panel Nucleic Acid Assay System
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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: MOL1452 | There is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc. | Class II | Open, Classified | |
| Z-1210-2023 | Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5. | 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. | Class II | Open, Classified | |
| 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 codes. | Class II | Open, Classified | |
| 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. Leakage from a well that had a positive sample may cause further cross-contamination in areas of the lab if not properly cleaned. | Class II | Open, Classified | |
| 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. | Class II | Open, Classified | |
| 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. | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. | Class II | Terminated | |
| 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). | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. | Class II | Terminated | |
| 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. | Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results. | Class II | Terminated | |
| Z-1686-2017 | Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila. | After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt. | Class II | Terminated | |
| Z-1685-2017 | Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila. | After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt. | Class II | Terminated | |
| Z-1274-2016 | Simplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2850, MOL1451, MOL1452, MOL1455 | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates. | Class I | Terminated | |
| Z-1273-2016 | Simplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2650, MOL1451, MOL1452, MOL1455 | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates. | Class I | Terminated | |
| Z-1272-2016 | Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455 | Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a false negative result, a false positive result or Error code (s) 500 or 505, and it may result in higher invalid rates. | Class I | Terminated | |
| Z-0238-2016 | Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic. | Focus Diagnostics is recalling the Anaplasma phagocytophilum IFA IgM kit because of the potential increase in invalid results. | Class II | Terminated | |
| Z-1454-2015 | STRATIFY JCV DxSelect, Model No. EL1950. Assay for detection of antibodies to JC Virus in human serum or plasma. In Vitro diagnostic. | Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. This could lead to a potential for false positive JCV results. | Class II | Terminated | |
| Z-1958-2014 | Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 Simplexa" Flu A/B & RSV Direct. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. | Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa" Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Amplification Disc storage. | Class II | Terminated | |
| Z-1144-2014 | Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. Model Number MOL2650. | Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV signals. | Class II | Terminated | |
| Z-0846-2014 | Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C. | Focus Diagnostics is initiating an urgent safety notice correction for Simplexa Flu A/B & RSV Direct assay (MOL2650) because Focus Diagnostics has received some customer complaints of Simplexa Flu A/B & RSV lots due to sporadic false positive RSV signals, which may result in a higher RSV false positive rate. | Class II | Terminated | |
| Z-0182-2013 | West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningoencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection. | The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate. | Class III | Terminated | |
| Z-1764-2008 | HerpeSelect 1 and 2 Immunoblot IgG Kit, IB0900G Intended for qualitatively detecting the presence or absence of human IgG class antibodies to HSV-1 and HSV-2 in human sera. | A small percentage of samples tested in specific lots, the HSV common antigen band appears lighter (less reactive) than the reading control band. Reduced reactivity of the common antigen band may lead to inaccurate interpretation of a sample as negative. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain