Diasorin Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 73
- Inspections
- 6
- Compliance Actions
- 0
Known Names
diasorin, diasorin molecular, diasorin italia
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0677-2025 | Class II | DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stoo | November 7, 2024 |
| Z-0815-2024 | Class II | DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620 | December 13, 2023 |
| Z-1342-2021 | Class II | LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended | November 23, 2020 |
| Z-2936-2020 | Class II | Parvovirus B19 IgG EIA kit Part No. V519IGUS | July 17, 2020 |
| Z-0645-2017 | Class II | LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chem | July 13, 2016 |
| Z-1464-2015 | Class II | DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II | March 16, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN250032 | LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) | December 23, 2025 |
| K231214 | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | October 27, 2023 |
| K223403 | LIAISON Anti-HAV; LIAISON XS | December 9, 2022 |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus | July 26, 2022 |
| K213936 | LIAISON MeMed BV, LIAISON MeMed BV Control Set | July 14, 2022 |
| K193650 | LIAISON Ferritin | September 14, 2021 |
| K202574 | LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus | February 18, 2021 |
| K202573 | LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus | February 18, 2021 |
| K210272 | LIAISON Anti-HAV | February 9, 2021 |
| K201908 | LIAISON Testosterone xt | October 15, 2020 |
| K192586 | LIAISON® Folate | May 6, 2020 |
| K193532 | LIAISON Anti-HAV Assay | March 2, 2020 |
| K193051 | LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set | January 29, 2020 |
| K192046 | LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set | October 28, 2019 |
| K192064 | LIAISON Vitamin B12 | October 2, 2019 |
| K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, | December 26, 2018 |
| K181464 | LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set | August 31, 2018 |
| K173683 | LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers | February 27, 2018 |
| K162969 | LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set | January 6, 2017 |
| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Ser | January 5, 2017 |