Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ItalyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list DiaSorin and its 5 subsidiaries with 178 510(k) clearances and 64 device recalls. The most recent is a 510(k) clearance dated Jun 15, 2026: LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, DiaSorin and its 5 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 15, 2026 | LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitK260333 · PGX | 510(k) clearances |
| Jun 4, 2026 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXK260770 · LOM | 510(k) clearances |
| May 19, 2026 | LIAISON PLEX Gastrointestinal Flex AssayK253722 · PCH | 510(k) clearances |
| Dec 23, 2025 | LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261)DEN250032 · SGW | 510(k) clearances |
| Dec 23, 2025 | LIAISON NES FLU A/B, RSV & COVID-19K251978 · QOF | 510(k) clearances |
| Oct 30, 2025 | Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)K252387 · QOF | 510(k) clearances |
| Jun 6, 2025 | LIAISON PLEX Gram-Positive Blood Culture AssayK243490 · PAM | 510(k) clearances |
| Apr 18, 2025 | LIAISON PLEX Gram-Negative Blood Culture AssayK243013 · PEN | 510(k) clearances |
| Nov 7, 2024 | DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimensClass II · Customer complaints were received alleging leaking devices and insufficient buffer volume. Diasorin's internal investiga | Device recalls |
| Dec 13, 2023 | DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620Class II · DiaSorin has identified that lots 136344, 136344A, 136344B, 136344C, 136520, 136520A, 136520B, 136520C, 136604, 136703, | Device recalls |
| Nov 23, 2020 | LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of paClass II · Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples. | Device recalls |
| Jul 17, 2020 | Parvovirus B19 IgG EIA kit Part No. V519IGUSClass II · Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value | Device recalls |
| Jul 13, 2016 | LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intendedClass II · DiaSorin is issuing an urgent medical device correction for the LIAISON¿ Estradiol II Gen assay. Due to the risk of a re | Device recalls |
| Mar 16, 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 reaClass II · Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
