Facility

DIASORIN INC.

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

Key facts

6recalls · worst Class II

2inspections · worst VAI

—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)	2182595
Establishment type	Manufacture Device in the United States for Export Only
Location	1951 Northwestern Ave Stillwater, MN, US 55082
Registration status	Active · expires 2026
Parent company	DiaSorin Inc. (owner-operator 9051149)
Brand names	LIAISON® Quick Detect COVID TrimericS Ab Control Set; LIAISON® Quick Detect COVID TrimericS Ab

Activity by year

Recalls (6)
Inspections (2)

Devices registered here (1)

Reagent, Coronavirus Serological
Product code QKO (opens in a new tab) · Not classified · Unknown

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 (2)

VAI2026-01-13
Voluntary Action Indicated · Bioresearch Monitoring
NAI2019-02-01
No Action Indicated · Bioresearch Monitoring

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 INC. (FEI 2182595) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2182595-diasorin-inc/

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