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Diasorin Inc.

Last updated September 17, 2026

Information

Country: US
Address: 1951 Northwestern Ave, Stillwater, MN, 55082
Website: diasorin.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 651-439-9710
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2182595
DUNS Number: 033429783

Catalogue (285)

Page 5 of 6

Device	Model / Reference	Registries	Class	Status
Copalis Ebv-M Antibody Assay	K991459	FDA 510(k)	Class I	Active
Liaison 25 Oh Vitamin D	K032844	FDA 510(k)	Class II	Active
Liaison 25 Oh Vitamin D Total Assay	K112725	FDA 510(k)	Class II	Active
LIAISON Anti-HAV; LIAISON XS	K223403	FDA 510(k)	Class II	Active
LIAISON MeMed BV, LIAISON MeMed BV Control Set	K213936	FDA 510(k)	Class II	Active
LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set	K162961	FDA 510(k)	Class I	Active
Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm Assays	K040120	FDA 510(k)	Class I	Active
25-Hydroxyvitamin D 125i Ria Kit	K983617	FDA 510(k)	Class I	Active
Liaison Hav Igm Assay, Liaison Control Hav Igm	K082050	FDA 510(k)	Class II	Active
Liaison 25 Oh Vitamin D Total; Assay, Control Set And Specimen Diluent Set, Models 310600, 310601 And 310602	K071480	FDA 510(k)	Class II	Active
LIAISON Anti-HAV	K210272	FDA 510(k)	Class II	Active
LIAISON Testosterone xt	K201908	FDA 510(k)	Class I	Active
LIAISON® Folate	K192586	FDA 510(k)	Class II	Active
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers	K150879	FDA 510(k)	Class II	Active
Liaison Rubella Igm, Liaison Control Rubella Igm	K122397	FDA 510(k)	Class II	Active
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT	K231214	FDA 510(k)	Class II	Active
LIAISON EBV IgM Serum Control Set	K161522	FDA 510(k)	Class I	Active
Copalis Treponemal Antigen Total Antibody Assay	K992552	FDA 510(k)	Class II	Active
Spq Test System	K982708	FDA 510(k)	Class II	Active
LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set	K162969	FDA 510(k)	Class II	Active
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set	K193051	FDA 510(k)	Class II	Active
Liaison N-Tact Pth	K033426	FDA 510(k)	Class II	Active
Eti-Max 3000	K052794	FDA 510(k)	Class I	Active
Eti-Ea-G Assay	K992191	FDA 510(k)	Class I	Active
LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device	K182698	FDA 510(k)	Class II	Active
Lipoprotein (a) Spq Iii Antibody Reagent Set	K993669	FDA 510(k)	Class II	Active
Liaison Anti-Hav Assay, Liaison Control Anti-Hav	K082049	FDA 510(k)	Class II	Active
LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers	K173683	FDA 510(k)	Class II	Active
Tsh-Ctk-3 Irma	K041014	FDA 510(k)	Class II	Active
Liaison Hsv-2 Type Specific Igg Assay, Control Hsv-2 Igg	K081687	FDA 510(k)	Class II	Active
Liaison Ea Igg	K060204	FDA 510(k)	Class I	Active
LIAISON Anti-HAV Assay	K193532	FDA 510(k)	Class II	Active
LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set	K161139	FDA 510(k)	Class I	Active
Liaison Ft4 Liaison Control Thyroid 1 Liaison Control Thyroid 2 Liaison Control Thyroid 3	K121951	FDA 510(k)	Class II	Active
Copalis Rubella Igm	K993291	FDA 510(k)	Class II	Active
LIAISON VZV IgG, LIAISON Control VZV IgG	K150375	FDA 510(k)	Class II	Active
LIAISON Ferritin	K193650	FDA 510(k)	Class II	Active
Liaison N-Tact Pth Calibration Verifiers Model 310913	K093498	FDA 510(k)	Class I	Active
Modification To Lipoprotein (a) Spq Iii Antibody Reagent Set	K001118	FDA 510(k)	Class II	Active
Liaison Aldosterone, Liaison Aldosterone Control Set, Liaison Aldosterone Calibration Verifiers	K130321	FDA 510(k)	Class II	Active
Diasorin Liason Rubella Igg Assay; Diasorin Liaison Rubella Igg Tri-Controls	K073390	FDA 510(k)	Class II	Active
LIAISON HAV IgM, LIAISON Control HAV IgM	K160650	FDA 510(k)	Class II	Active
Transferrin Spq Iii Antibody Reagent Set	K983880	FDA 510(k)	Class II	Active
Liason Xl1, 25 Dihydroxyvitamin D; Control Set, Calibration Verifiers	K141463	FDA 510(k)	Class II	Active
LIAISON Vitamin B12	K192064	FDA 510(k)	Class II	Active
Liaison Tsh, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control Thyroid 3	K130469	FDA 510(k)	Class II	Active
Liaison Xl Analyzer	K141116	FDA 510(k)	Class II	Active
Liaison(r) Toxo Igg Ii, Liaison(r) Control Toxo Igg Ii	K132234	FDA 510(k)	Class II	Active
Liaison Xl Hcg	K131037	FDA 510(k)	Class II	Active
Liaison Hsv-1 Type Specific Igg Assay, Control Hsv-1 Igg	K081685	FDA 510(k)	Class II	Active

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FDA Recalls (39)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 7, 2024	Z-0677-2025	—	open, classified	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.
Dec 13, 2023	Z-0815-2024	—	open, classified	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.
Nov 23, 2020	Z-1342-2021	—	terminated	Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
Jul 17, 2020	Z-2936-2020	—	open, classified	Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value
Jul 13, 2016	Z-0645-2017	—	terminated	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).
Mar 16, 2015	Z-1464-2015	—	terminated	Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.
Aug 19, 2010	Z-1744-2011	—	terminated	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
Dec 16, 2009	Z-0922-2010	—	terminated	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.
Oct 12, 2009	Z-1914-2010	—	terminated	The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.
Dec 5, 2008	Z-1042-2009	—	terminated	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.
Feb 1, 2008	Z-1240-2008	—	terminated	Inaccurate measurements: Kits may sporadically recover kit and external control values out of range high.
Aug 21, 2007	Z-1237-2007	—	terminated	25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.
Mar 14, 2007	Z-0755-2007	—	terminated	A lot to lot inconsistency was noted on kits of ETI EBNA G.
Feb 15, 2007	Z-0748-2007	—	terminated	Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)
Jun 5, 2006	Z-0707-2007	—	terminated	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)
Aug 8, 2005	Z-0557-06	—	terminated	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.
Apr 8, 2005	Z-0776-05	—	terminated	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).
Mar 16, 2005	Z-0784-05	—	terminated	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.
Feb 14, 2005	Z-0637-05	—	terminated	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.
Feb 14, 2005	Z-0638-05	—	terminated	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.
Jan 18, 2005	Z-0706-05	—	terminated	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.
Jan 10, 2005	Z-0636-05	—	terminated	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.
Nov 1, 2004	Z-0927-05	—	terminated	DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL).
Nov 1, 2004	Z-0658-05	—	terminated	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.
Oct 26, 2004	Z-0674-05	—	terminated	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.
Oct 20, 2004	Z-0633-05	—	terminated	2 lots of ETI-MP IgM assay kits showed a decline in Optical Density (OD) reading of the positive control and calibrators, P10 and P50. The decline in OD of the positive control and calibrators (P10 & P50) would cause the assay validation criteria to fail.
Sep 24, 2004	Z-0807-05	—	terminated	A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the 'refresh button' has not been pressed. The graph may appear valid; however erroneous results may occur.
Jul 15, 2004	Z-0634-05	—	terminated	Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.
Jun 30, 2004	Z-0676-05	—	terminated	The program for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160.
Jun 30, 2004	Z-0705-05	—	terminated	An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18.
May 25, 2004	Z-0704-05	—	terminated	Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria failed when the gelatinous standards were used.
May 20, 2004	Z-0703-05	—	terminated	When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model ELx50, the software did not automatically clear old versions of the wash program when new ones were added.
Apr 20, 2004	Z-0672-05	—	terminated	An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.
Apr 12, 2004	Z-0675-05	—	terminated	The data reduction program written for a specific automated microtiter plate reader (Bio-Tek ELx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay. The negative Control Upper Limit should be less than 0.95, rather than less than 1.0.
Apr 12, 2004	Z-0702-05	—	terminated	The software program written for use in the automated microtiter plate reader (Bio-Tek ELx800) for use with the Pro-Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert.
Apr 12, 2004	Z-0673-05	—	terminated	The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.
Mar 9, 2004	Z-1576-05	—	terminated	An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay.
Jan 23, 2004	Z-0632-05	—	terminated	DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.
Sep 10, 2003	Z-0572-05	—	terminated	Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results.