The Recall Desk

Manufacturer

Diasorin Inc.

6 recalls in our database name Diasorin Inc. as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2024-12-18

Of the 6 recalls from Diasorin Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • HighFDA (Devices)·Z-0677-2025·2024-12-18

    DiaSorin LIAISON Device Recall: Loose Caps May Cause Incorrect Patient Test Results

    DiaSorin Inc. is recalling over 21,900 LIAISON Q.S.E.T. Device Plus units worldwide due to loose caps that may leak buffer, potentially resulting in incorrect stool sample test results.

    Product
    DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stool specimens
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0815-2024·2024-01-31

    FDA Recalls DiaSorin HSV-2 Antibody Test Lots Due to False Positive Results

    DiaSorin LIAISON HSV-2 Type Specific IgG test kits are being recalled because specific lots may produce false positive or equivocal results. Affected kits were distributed in the US and Canada.

    Product
    DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1342-2021·2021-04-07

    Diasorin Recalls LIAISON 1-84 PTH Assay Due to Falsely Elevated Results

    Diasorin Inc. is recalling LIAISON 1-84 PTH Assay kits because the system may produce falsely elevated parathyroid hormone results.

    Product
    LIAISON 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 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2936-2020·2020-09-09

    Diasorin Recalls Parvovirus B19 IgG EIA Kit Due to Labeling Error

    Diasorin Inc. is recalling 615 units of the Parvovirus B19 IgG EIA kit because the printed label inside the box lid contains an incorrect Lot Specific Constant value.

    Product
    Parvovirus B19 IgG EIA kit Part No. V519IGUS
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0645-2017·2016-11-30

    DiaSorin Recalls LIAISON Estradiol II Gen Assay Due to Cross-Reactivity

    DiaSorin is recalling the LIAISON Estradiol II Gen assay because it may produce inaccurate results for patients treated with fulvestrant.

    Product
    LIAISON 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 laborat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1464-2015·2015-04-29

    DiaSorin Recalls PRO-Trac II Tacrolimus ELISA Kits Due to Instability

    DiaSorin is recalling 451 PRO-Trac II Tacrolimus ELISA kits because instability may cause falsely elevated patient results.

    Product
    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 reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized w
    Category
    Medical Device
    Distribution
    1 state

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

DiaSorin

Italian biotechnoloty company

Country
Italy
Founded
2000

Official website

Source: Wikidata (Q3706466), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.