RegWardenFDA facility compliance records
Company

DiaSorin Inc.

6 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2015: 1 recalls; 2016: 1 recalls; 2020: 2 recalls; 2023: 1 recalls; 2024: 1 recalls12015120162017201820192202020212022120231202420252026
  • Recalls (6)

Registered facilities (5)

Recalls & enforcement

  • Class IIOngoing2024-11-07
    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 sto…
  • Class IIOngoing2023-12-13
    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 IITerminated2020-11-23
    Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
  • Class IIOngoing2020-07-17
    Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value
  • Class IITerminated2016-07-13
    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 IITerminated2015-03-16
    Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “DiaSorin Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9051149-diasorin-inc/

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