DiaSorin, Inc.
Medical device manufacturer in Stillwater, MN.
71510(k) clearances
23PMA approvals
15recalls
Device types
- LOL Hepatitis A Test (Antibody And Igm Antibody) 8
- MRG System, Test, Vitamin D 6
- LSE Epstein-Barr Virus, Other 5
- JJX Single (Specified) Analyte Controls… 4
- LSR Reagent, Borrelia Serological Reagent 4
- DFC Lipoprotein, Low-Density, Antigen… 3
- LFX Enzyme Linked Immunoabsorbent Assay, Rubella 3
- CEW Radioimmunoassay, Parathyroid Hormone 3
- LFY Enzyme Linked Immunoabsorbent Assay… 3
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 2
- CDZ Radioimmunoassay, Testosterones And… 2
- LGD Enzyme Linked Immunoabsorbent Assay… 2
- LYR Helicobacter Pylori 2
- NXO Calprotectin, Fecal 2
- LIP Enzyme Linked Immunoabsorption Assay… 2
- LFZ Enzyme Linked Immunoabsorbent Assay… 2
- LLM Test, Antigen, Nuclear, Epstein-Barr Virus 1
- LCI Automated Radioimmunoassay Systems, For… 1
- MYF Enzyme Linked Immunosorbent Assay, Herpes… 1
- LJN Antibody Igm, If, Epstein-Barr Virus 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXLOM · Traditional | 06/04/2026SE |
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HTLFY · Traditional | 10/27/2023SE |
| K223403 | LIAISON Anti-HAV; LIAISON XSLOL · Special | 12/09/2022SE |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusNXO · Traditional | 07/26/2022SE |
| K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control SetQPS · Traditional | 07/14/2022SE |
| K193650 | LIAISON FerritinDBF · Traditional | 09/14/2021SE |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional | 02/18/2021SE |
| K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody PlusLSR · Traditional | 02/18/2021SE |
| K210272 | LIAISON Anti-HAVLOL · Special | 02/09/2021SE |
| K201908 | LIAISON Testosterone xtCDZ · Special | 10/15/2020SE |
| K192586 | LIAISON® FolateCGN · Traditional | 05/06/2020SE |
| K193532 | LIAISON Anti-HAV AssayLOL · Traditional | 03/02/2020SE |
| K193051 | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control SetLSR · Traditional | 01/29/2020SE |
| K192046 | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control SetQFO · Traditional | 10/28/2019SE |
| K192064 | LIAISON Vitamin B12CDD · Traditional | 10/02/2019SE |
| K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…NXO · Traditional | 12/26/2018SE |
| K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetLYR · Traditional | 08/31/2018SE |
| K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN…PRI · Traditional | 02/27/2018SE |
| K162969 | LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetLFZ · Special | 01/06/2017SE |
| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON®…LSE · Special | 01/05/2017SE |
| K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetLSE · Special | 01/04/2017SE |
| K160650 | LIAISON HAV IgM, LIAISON Control HAV IgMLOL · Traditional | 08/25/2016SE |
| K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetLYR · Traditional | 07/22/2016SE |
| K161526 | LIAISON CMV IgM Serum Control SetJJX · Special | 06/30/2016SE |
| K161522 | LIAISON EBV IgM Serum Control SetJJX · Special | 06/30/2016SE |
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersCEW · Traditional | 06/22/2015SE |
| K150375 | LIAISON VZV IgG, LIAISON Control VZV IgGLFY · Special | 03/11/2015SE |
| K141463 | Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersMRG · Traditional | 12/10/2014SE |
| K141116 | Liaison XL AnalyzerLOL · Traditional | 07/25/2014SE |
| K132515 | Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersCEW · Traditional | 11/08/2013SE |
| K131037 | Liaison XL HCGDHA · Traditional | 09/06/2013SE |
| K132492 | Liaison 25 Total-DMRG · Traditional | 09/05/2013SE |
| K132234 | Liaison(R) Toxo Igg II, Liaison(R) Control Toxo Igg IILGD · Traditional | 08/28/2013SE |
| K131441 | Liaison Toxo Igm II, Liaison Control Toxo Igm IILGD · Traditional | 08/09/2013SE |
| K130321 | Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration…CJM · Traditional | 04/09/2013SE |
| K130469 | Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control…JLW · Traditional | 04/05/2013SE |
| K121951 | Liaison FT4 Liaison Control Thyroid 1 Liaison Control Thyroid 2 Liaison Control Thyroid 3CEC · Traditional | 04/04/2013SE |
| K122793 | Liaison Testosterone; Liaison Testosterone Control SetCDZ · Traditional | 01/25/2013SE |
| K121944 | Liaison Direct Renin Liaison Control Direct Renin Liaison Endocrinology DiluentCIB · Traditional | 01/01/2013SE |
| K122397 | Liaison Rubella Igm, Liaison Control Rubella IgmLFX · Traditional | 09/06/2012SE |
| K112725 | Liaison 25 Oh Vitamin D Total AssayMRG · Traditional | 01/20/2012SE |
| K103529 | Liaison XL Analyzer Model 10050LOL · Traditional | 01/21/2011SE |
| K093498 | Liaison N-Tact PTH Calibration Verifiers Model 310913JJX · Traditional | 12/14/2009SE |
| K090104 | Liaison 25 Oh Vitamin D Total Calibration Verifiers, Model: 310603JJX · Traditional | 09/09/2009SE |
| K082049 | Liaison Anti-Hav Assay, Liaison Control Anti-HavLOL · Traditional | 12/05/2008SE |
| K073390 | Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-ControlsLFX · Traditional | 11/21/2008SE |
| K081685 | Liaison HSV-1 Type Specific Igg Assay, Control HSV-1 IggMXJ · Traditional | 11/18/2008SE |
| K081687 | Liaison HSV-2 Type Specific Igg Assay, Control HSV-2 IggMYF · Traditional | 11/10/2008SE |
| K082050 | Liaison Hav Igm Assay, Liaison Control Hav IgmLOL · Traditional | 11/03/2008SE |
| K071480 | Liaison 25 Oh Vitamin D Total; Assay, Control Set and Specimen Diluent Set, Models…MRG · Traditional | 10/01/2007SE |
| K062473 | Liaison Borrelia Igg/Igm Assay, Model 310870; Serum Controls, Model 310871LSR · Traditional | 04/12/2007SE |
| K061820 | Diasorin Liaison VZV IggLFY · Traditional | 02/26/2007SE |
| K060204 | Liaison Ea IggLSE · Traditional | 10/18/2006SE |
| K061247 | Diasorin Liaison Treponema AssayLIP · Traditional | 07/31/2006SE |
| K052794 | Eti-Max 3000JJF · Traditional | 03/31/2006SE |
| K040120 | Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysLLM · Traditional | 04/29/2005SE |
| K041014 | TSH-CTK-3 IrmaJLW · Traditional | 07/14/2004SE |
| K033426 | Liaison N-Tact PTHCEW · Traditional | 02/12/2004SE |
| K032844 | Liaison 25 Oh Vitamin DMRG · Traditional | 02/12/2004SE |
| K014030 | 1,25-DIHYDROXYVITAMIN D125I RiaMRG · Traditional | 03/26/2002SE |
| K001118 | Modification to Lipoprotein (a) SPQ III Antibody Reagent SetDFC · Special | 04/25/2000SE |
| K993291 | Copalis Rubella IgmLFX · Traditional | 02/10/2000SE |
| K992552 | Copalis Treponemal Antigen Total Antibody AssayLIP · Traditional | 12/16/1999SE |
| K993669 | Lipoprotein (a) SPQ III Antibody Reagent SetDFC · Special | 11/17/1999SE |
| K992191 | Eti-Ea-G AssayLSE · Traditional | 07/12/1999SE |
| K991660 | Copalis Multiplex Ebv Antibody AssayLSE · Traditional | 06/04/1999SE |
| K991459 | Copalis Ebv-M Antibody AssayLJN · Traditional | 05/14/1999SE |
| K982708 | SPQ Test SystemDFC · Traditional | 04/02/1999SE |
| K983880 | Transferrin SPQ III Antibody Reagent SetDDG · Traditional | 12/18/1998SE |
| K982027 | Modification to Copalis CMV Total Antibody AssayLFZ · Traditional | 11/25/1998SE |
| K983617 | 25-HYDROXYVITAMIN D 125I Ria KitLCI · Special | 11/16/1998SE |
PMA approvals
- P250039 LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM Plus · 05/07/2026 · 1 supplement
- P220034 LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus · 03/29/2024 · 10 supplements
- P190017 LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test · 08/29/2020 · 25 supplements
- P180049 LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBe · 08/29/2020 · 19 supplements
- P180048 LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg · 08/29/2020 · 19 supplements
- P180045 LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM · 08/29/2020 · 19 supplements
- P180039 LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs Verifiers · 02/21/2020 · 21 supplements
- P180038 LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc · 01/02/2020 · 26 supplements
- P180047 LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON Software · 11/26/2019 · 41 supplements
- P190011 LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV Ab · 10/18/2019 · 3 supplements
- P990045 Diasorin Eti-Ab-Corek Plus Assay · 03/30/2001 · 25 supplements
- P990044 Diasorin Eti-Core-Igmk Plus Assay · 03/30/2001 · 26 supplements
- P990042 Diasorin Eti-Ab-Auk Plus Assay · 03/30/2001 · 26 supplements
- P990041 Diasorin Eti-Ab-Ebk Plus Assay · 03/30/2001 · 28 supplements
- P990038 Diasorin Eti MAK-2 Plus Assay · 03/30/2001 · 28 supplements
- P990043 Diasorin Eti-Ebk Plus Assay · 02/08/2001 · 28 supplements
- P970055 Biotrin Parvovirus Igm Eia (V619IMUS) · 08/06/1999 · 21 supplements
- P970054 Biotrin Parvovirus B19 Igg · 08/06/1999 · 18 supplements
- P970025 Pro-Trac II Tacrolimus Elisa Kit · 04/27/1999 · 0 supplements
- P890065 Cyclo-Trac SP Whole Blood & Serum/Plasma Assays · 09/28/1990 · 1 supplement
- P890014 Ha-Igmk and Eti-Ha-Igmk · 07/24/1990 · 7 supplements
- P890019 AB -Havk · 07/13/1990 · 7 supplements
- P870048 Ebk · 07/13/1990 · 2 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0677-2025 Class II | DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation…Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's… | 11/07/2024Open, Classified |
| Z-0815-2024 Class II | DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C… | 12/13/2023Open, Classified |
| Z-1342-2021 Class II | LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay…Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples. | 11/23/2020Terminated |
| Z-2936-2020 Class II | Parvovirus B19 IgG EIA kit Part No. V519IGUSPrinted label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value | 07/17/2020Open, Classified |
| Z-0645-2017 Class II | LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay…DiaSorin is issuing an urgent medical device correction for the LIAISON Estradiol II Gen assay. Due to the… | 07/13/2016Terminated |
| Z-1464-2015 Class II | DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The…Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results. | 03/16/2015Terminated |
| Z-1744-2011 | ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy…Through internal testing, DiaSorin has become aware that the kit lots identified (ETI-AB-AUK PLUS kits… | 08/19/2010Terminated |
| Z-0922-2010 | DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951…DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two… | 12/16/2009Terminated |
| Z-1914-2010 | GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 (…The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range. | 10/12/2009Terminated |
| Z-1042-2009 | Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer…DiaSorin determined that there was a potential for a short to occur in a a residual starter pump electrical… | 12/05/2008Terminated |
| Z-1240-2008 | LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc…Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high. | 02/01/2008Terminated |
| Z-1237-2007 | 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater…25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer. | 08/21/2007Terminated |
| Z-0755-2007 | DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative…A lot to lot inconsistency was noted on kits of ETI EBNA G. | 03/14/2007Terminated |
| Z-0748-2007 | DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the…Assay Failure: Assay failures may occur due to the kit control running outside of the established range… | 02/15/2007Terminated |
| Z-0707-2007 | 1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25…Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to… | 06/05/2006Terminated |