Recall Register

Food, drugs, devices › Firms

Diasorin Inc.

FDA recalling firm · 6 enforcement events · 6 product records · 2015–2024 · MN

Diasorin Inc. has 6 FDA enforcement events on this register (6 product records) between 2015 and 2024: 6 device; the busiest year was 2020 with 2.

0% of its events are Class I; the most common class is Class II (6). 3 events are listed as ongoing; the recalling firm's address is in MN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
7 Nov 2024DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimensDeviceClass II1Ongoing
13 Dec 2023DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620DeviceClass II1Ongoing
23 Nov 2020LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia…DeviceClass II1Terminated
17 Jul 2020Parvovirus B19 IgG EIA kit Part No. V519IGUSDeviceClass II1Ongoing
13 Jul 2016LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and…DeviceClass II1Terminated
16 Mar 2015DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid in the management…DeviceClass II1Terminated

By type and class

Device6
Class II6

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

15
16
17
18
19
20
21
22
23
24
25
26
Enforcement events for Diasorin Inc. by year initiated.

Questions and answers

How many FDA recalls has Diasorin Inc. had?

6 enforcement events (6 product records) on this register, 2015–2024: 6 device.

Are any Diasorin Inc. recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are Diasorin Inc. recalls?

6 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.