DiaSorin, Inc.
DiaSorin, Inc. holds FDA 510(k) medical device clearances, first cleared 1998, most recent 2026, with 6 FDA device recalls on record.
Top product codes for DiaSorin, Inc.
FDA recalls by DiaSorin, Inc.
- Z-0677-2025 — DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
- Z-0815-2024 — DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
- 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.
- Z-2936-2020 — Parvovirus B19 IgG EIA kit Part No. V519IGUS
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by DiaSorin, Inc.
- K260770 — LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX
- DEN250032 — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)
- K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
- K223403 — LIAISON Anti-HAV; LIAISON XS
- K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
- K213936 — LIAISON MeMed BV, LIAISON MeMed BV Control Set
- K193650 — LIAISON Ferritin
- K202573 — LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
- K202574 — LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
- K210272 — LIAISON Anti-HAV
- K201908 — LIAISON Testosterone xt
- K192586 — LIAISON® Folate
- K193532 — LIAISON Anti-HAV Assay
- K193051 — LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
- K192046 — LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set
- K192064 — LIAISON Vitamin B12
- K182698 — LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device
- K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
- K173683 — LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
- K162969 — LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
- K162961 — LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
- K162959 — LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
- K160650 — LIAISON HAV IgM, LIAISON Control HAV IgM
- K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set
- K161522 — LIAISON EBV IgM Serum Control Set
- K161526 — LIAISON CMV IgM Serum Control Set
- K150879 — LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
- K150375 — LIAISON VZV IgG, LIAISON Control VZV IgG
- K141463 — LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS
- K141116 — LIAISON XL ANALYZER
- K132515 — LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
- K131037 — LIAISON XL HCG
- K132492 — LIAISON 25 TOTAL-D
- K132234 — LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II
- K131441 — LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM II
- K130469 — LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3
- K121951 — LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3
- K122793 — LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET
- K121944 — LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT
- K122397 — LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
- K112725 — LIAISON 25 OH VITAMIN D TOTAL ASSAY
- K103529 — LIAISON XL ANALYZER MODEL 10050
- K093498 — LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913
- K090104 — LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603
- K082049 — LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV
- K073390 — DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS
- K081685 — LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
- K081687 — LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
- K082050 — LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM
- K071480 — LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602
- K062473 — LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871
- K061820 — DIASORIN LIAISON VZV IGG
- K060204 — LIAISON EA IGG
- K061247 — DIASORIN LIAISON TREPONEMA ASSAY
- K052794 — ETI-MAX 3000
- K040120 — DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS
- K041014 — TSH-CTK-3 IRMA
- K032844 — LIAISON 25 OH VITAMIN D
- K033426 — LIAISON N-TACT PTH
- K014030 — 1,25-DIHYDROXYVITAMIN D125I RIA
- K001118 — MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
- K993291 — COPALIS RUBELLA IGM
- K992552 — COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
- K993669 — LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
- K992191 — ETI-EA-G ASSAY
- K991660 — COPALIS MULTIPLEX EBV ANTIBODY ASSAY
- K991459 — COPALIS EBV-M ANTIBODY ASSAY
- K982708 — SPQ TEST SYSTEM
- K983880 — TRANSFERRIN SPQ III ANTIBODY REAGENT SET
- K982027 — MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY
- K983617 — 25-HYDROXYVITAMIN D 125I RIA KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.