Diasorin Inc.
Stillwater, MN, US
DIASORIN INC. appears in FDA device records in Stillwater, MN. FDA records list 74 510(k) clearances between and , 421 PMA records and one registered establishment. As of , FDA records show 39 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 74FDA records hold 74 510(k) clearances for Diasorin Inc. between 1998 and 2026. The busiest year on record is 2013, with 10. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 3 |
| 1999 | 6 |
| 2000 | 2 |
| 2002 | 1 |
| 2004 | 3 |
| 2005 | 2 |
| 2006 | 4 |
| 2007 | 3 |
| 2008 | 5 |
| 2009 | 2 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 10 |
| 2014 | 2 |
| 2015 | 2 |
| 2016 | 4 |
| 2017 | 3 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 4 |
| 2021 | 4 |
| 2022 | 3 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | LOM | Substantially Equivalent | |
| DEN250032 | LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) | SGW | Unknown | |
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | LFY | Substantially Equivalent | |
| K223403 | LIAISON Anti-HAV; LIAISON XS | LOL | Substantially Equivalent | |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | NXO | Substantially Equivalent | |
| K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control Set | QPS | Substantially Equivalent | |
| K193650 | LIAISON Ferritin | DBF | Substantially Equivalent | |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus | LSR | Substantially Equivalent | |
| K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus | LSR | Substantially Equivalent | |
| K210272 | LIAISON Anti-HAV | LOL | Substantially Equivalent | |
| K201908 | LIAISON Testosterone xt | CDZ | Substantially Equivalent | |
| K192586 | LIAISON® Folate | CGN | Substantially Equivalent | |
| K193532 | LIAISON Anti-HAV Assay | LOL | Substantially Equivalent | |
| K193051 | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set | LSR | Substantially Equivalent | |
| K192046 | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set | QFO | Substantially Equivalent | |
| K192064 | LIAISON Vitamin B12 | CDD | Substantially Equivalent | |
| K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device | NXO | Substantially Equivalent | |
| K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set | LYR | Substantially Equivalent | |
| K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers | PRI | Substantially Equivalent | |
| K162969 | LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set | LFZ | Substantially Equivalent | |
| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set | LSE | Substantially Equivalent | |
| K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set | LSE | Substantially Equivalent | |
| K160650 | LIAISON HAV IgM, LIAISON Control HAV IgM | LOL | Substantially Equivalent | |
| K161139 | LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set | LYR | Substantially Equivalent | |
| K161526 | LIAISON CMV IgM Serum Control Set | JJX | Substantially Equivalent | |
| K161522 | LIAISON EBV IgM Serum Control Set | JJX | Substantially Equivalent | |
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers | CEW | Substantially Equivalent | |
| K150375 | LIAISON VZV IgG, LIAISON Control VZV IgG | LFY | Substantially Equivalent | |
| K141463 | LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS | MRG | Substantially Equivalent | |
| K141116 | LIAISON XL ANALYZER | LOL | Substantially Equivalent | |
| K132515 | LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS | CEW | Substantially Equivalent | |
| K131037 | LIAISON XL HCG | DHA | Substantially Equivalent | |
| K132492 | LIAISON 25 TOTAL-D | MRG | Substantially Equivalent | |
| K132234 | LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II | LGD | Substantially Equivalent | |
| K131441 | LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II | LGD | Substantially Equivalent | |
| K130321 | LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS | CJM | Substantially Equivalent | |
| K130469 | LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 | JLW | Substantially Equivalent | |
| K121951 | LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 | CEC | Substantially Equivalent | |
| K122793 | LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET | CDZ | Substantially Equivalent | |
| K121944 | LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT | CIB | Substantially Equivalent | |
| K122397 | LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM | LFX | Substantially Equivalent | |
| K112725 | LIAISON 25 OH VITAMIN D TOTAL ASSAY | MRG | Substantially Equivalent | |
| K103529 | LIAISON XL ANALYZER MODEL 10050 | LOL | Substantially Equivalent | |
| K093498 | LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 | JJX | Substantially Equivalent | |
| K090104 | LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603 | JJX | Substantially Equivalent | |
| K082049 | LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV | LOL | Substantially Equivalent | |
| K073390 | DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS | LFX | Substantially Equivalent | |
| K081685 | LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG | MXJ | Substantially Equivalent | |
| K081687 | LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG | MYF | Substantially Equivalent | |
| K082050 | LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM | LOL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2182595 | 2182595 | DIASORIN INC. | 1951 Northwestern Ave, Stillwater, MN 55082 US | 2026 | and 36 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- DCFAlbumin, Antigen, Antiserum, Control
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- LJNAntibody Igm, If, Epstein-Barr Virus
- MCBAntigen, C. Difficile
- GMZAntigens, All Types, Escherichia Coli
- GODAntigens, Cf (Including Cf Control), Adenovirus 1-33
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- MSJApolipoproteins
- MZOAssay, Enzyme Linked Immunosorbent, Hepatitis C Virus
- MYLAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
- MYMAssay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
- LCIAutomated Radioimmunoassay Systems, For Clinical Use
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- NXOCalprotectin, Fecal
- LQPCampylobacter Spp.
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- DAEComplement C9, Antigen, Antiserum, Control
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
- MLMEnzyme Immunoassay, Tracrolimus
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- LIPEnzyme Linked Immunoabsorption Assay, Treponema Pallidum
- MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
- MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
- LSEEpstein-Barr Virus, Other
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- DBFFerritin, Antigen, Antiserum, Control
- LYRHelicobacter Pylori
- LOLHepatitis A Test (Antibody And Igm Antibody)
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JNNP-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin
- CDDRadioassay, Vitamin B12
- MGVRadioimmunoassay For Cyclosporine
- CJMRadioimmunoassay, Aldosterone
- CIZRadioimmunoassay, Androstenedione
- CIBRadioimmunoassay, Angiotensin I And Renin
- JKRRadioimmunoassay, Calcitonin
- CHPRadioimmunoassay, Estradiol
- CECRadioimmunoassay, Free Thyroxine
- CEWRadioimmunoassay, Parathyroid Hormone
- JLSRadioimmunoassay, Progesterone
- CDZRadioimmunoassay, Testosterones And Dihydrotestosterone
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- LSRReagent, Borrelia Serological Reagent
- MVUReagents, Specific, Analyte
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DHASystem, Test, Human Chorionic Gonadotropin
- NEOSystem, Test, Osteocalcin
- MRGSystem, Test, Vitamin D
- LLMTest, Antigen, Nuclear, Epstein-Barr Virus
- LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- NCDTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis
- DDGTransferrin, Antigen, Antiserum, Control
Recall records
Showing 25 of 39| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0677-2025 | DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens | Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investigation determined that 0.14% of the LIAISON Q.S.E.T. Device Plus in the lots identified have loose clear caps, which may allow buffer to leak from the tube. A stool sample prepared with less than the correct amount of buffer may result an incorrectly high patient result. | Class II | Open, Classified | |
| Z-0815-2024 | DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 | DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, 136703A, 136703B, 136703C 136775of LIAISON HSV-2 Type Specific IgG assay may produce increased equivocal and/or false positive results. | Class II | Open, Classified | |
| Z-1342-2021 | LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test has to be performed on the LIAISON Analyzer family. | Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples. | Class II | Terminated | |
| Z-2936-2020 | Parvovirus B19 IgG EIA kit Part No. V519IGUS | Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value | Class II | Open, Classified | |
| Z-0645-2017 | LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and management of conditions involving an excess or deficiency of estradiol. The test has to be performed on the LIAISON Analyzer Family. | DiaSorin is issuing an urgent medical device correction for the LIAISON Estradiol II Gen assay. Due to the risk of a recently identified cross reactivity, the LIAISON Estradiol II Gena assay should not be used to test patients being treated with fulvestrant (Faslodex). | Class II | Terminated | |
| Z-1464-2015 | DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management of liver transplant patients receiving tacrolimus therapy. | Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results. | Class II | Terminated | |
| Z-1744-2011 | ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma. | Through internal testing, DiaSorin has become aware that the kit lots identified (ETI-AB-AUK PLUS kits, catalog number P001931, lot numbers 0650270A and/or 0650270A/1) may not consistently exhibit stability to defined expiration dating, resulting in decreased binding and lower absorbance. Internal testing has confirmed that when defined assay validation criteria pass, analytical performance is co | Terminated | ||
| Z-0922-2010 | DiaSorin Rubella IgG ELISA Kit, Cat. # 7545, 2 x 6 Wells, DiaSorin Inc., 1951 northwestern Avenue, Stillwater, MN 55082-0285, Lot 123127A, Exp. 2010//07/28. | DiaSorin Rubella IgG kits of lot 123127A were packed with one coated microtiter plate instead of two microtiter plates as indicated in the product labeling. The risk is the possibility of delayed patient test results. | Terminated | ||
| Z-1914-2010 | GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit), DiaSorin, Stillwater, Minnesota 55082-0285. Indicated for the quantitative determination of plasma renin activity (PRA) by the radioimmunoassay of generated angiotension I. | The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range. | Terminated | ||
| Z-1042-2009 | Diasorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for clinical use. | DiaSorin determined that there was a potential for a short to occur in a a residual starter pump electrical cable in the LIAISON (R) Analyzer. | Terminated | ||
| Z-1240-2008 | LIAISON 25-OH Viatamin D Kit, Vitamin D test system, Model Number 310900, DiaSorin Inc, Stillwater, MN 55082 | Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high. | Terminated | ||
| Z-1237-2007 | 25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. | 25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer. | Terminated | ||
| Z-0755-2007 | DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285 | A lot to lot inconsistency was noted on kits of ETI EBNA G. | Terminated | ||
| Z-0748-2007 | DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used as a procedure for the quantitative determination of trypsin-like immunoreactiviy (TLI) in human serum or plasma samples) | Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay) | Terminated | ||
| Z-0707-2007 | 1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma-DiaSorin, Stillwater, Minnesota 55082-0285, USA | Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the defined range, the run is considered invalid) | Terminated | ||
| Z-0557-06 | The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1). | Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error occurs when running a combined plate on the ETI-Max 3000, with the ETI-Mumps IgG assay as the second assay on a combined plate with ETI-Measles IgG and/or ETI-VZV IgG. | Terminated | ||
| Z-0776-05 | DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Manufactured by: DiaSorin S.p.A. Saluggia, Italy | The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the instructions for Hepatitus A virus Total antibody test (ETI-AB-HAVK Plus, catalog P001926). | Terminated | ||
| Z-0784-05 | Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2. | Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter. | Terminated | ||
| Z-0638-05 | Liaison 25 OH Vitamin D Assay, Manufacturer part #310900, Lot #114668 | An internal inspection indicates that Calibrator 2 and Conjugate are switched in their positions in the integral. This will result in Calibrator 1 RLU's similar to that of background RLU, and Calibrator 2 RLU's near expected range. A curve can not be calculated from this data. | Terminated | ||
| Z-0637-05 | LIAISON 25 OH Vitamin D Assay, Manufacturer part # 310900, Lot # 114439E. | Results of an internal inspection show Lot 114439E to have calibrator 1 and Calibrator 2 switched in their position in the integral. This results in an inability to calculate a curve, due to the reversal of calibrator values. | Terminated | ||
| Z-0706-05 | DiaSorin Analyte Specific Reagent | Expiration date of 2005/1/6 stamped on vial label of Anti-Human igG, Fluorescein Conjugate is incorrect. Correct expiration date is 2006/1/6. | Terminated | ||
| Z-0636-05 | Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, Lot #s 1144332, 114432A,13656, 113656A, and 113656B for use in DiaSorin Antibody Reagent Set for Lp(a) SPQ Test System . | QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was determined that the Lp(a) diluent, part #238017 was the cause of the failing background specification. | Terminated | ||
| Z-0658-05 | DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C | The DiaSorin ETI-EA-G kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the ProTrac II Tacrolimus kit. | Terminated | ||
| Z-0927-05 | DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom. | DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL). | Terminated | ||
| Z-0674-05 | Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit. | Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain