Facility

DiaSorin Italia S.p.A.

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

Key facts

6recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002808212
Establishment type	Manufacture Medical Device
Location	VIA CRESCENTINO, snc SALUGGIA Vercelli, IT 13040
Registration status	Active · expires 2026
Parent company	DiaSorin Inc. (owner-operator 9051149)
Brand names	LIAISON EBNA IgG Serum Control Set; LIAISON VCA IgG Serum Control Set

Activity by year

Recalls (6)
Inspections (1)

Devices registered here (3)

Epstein-Barr Virus, Other
Product code LSE (opens in a new tab) · Class I · Microbiology · 21 CFR 866.3235
Test, Antigen, Nuclear, Epstein-Barr Virus
Product code LLM (opens in a new tab) · Class I · Microbiology · 21 CFR 866.3235
Single (Specified) Analyte Controls (Assayed And Unassayed)
Product code JJX (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1660

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.

FDA inspections (1)

NAI2023-02-06
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “DiaSorin Italia S.p.A. (FEI 3002808212) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002808212-diasorin-italia-s-p-a/

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