The Recall Desk

Manufacturer

Immunotech A.S.

2 recalls in our database name Immunotech A.S. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2026-02-25

Of the 2 recalls from Immunotech A.S. 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.

1–2 of 2

  • HighFDA (Devices)·Z-1369-2026·2026-02-25

    Estrone RIA Diagnostic Kit Recall by Immunotech A.S.

    Immunotech A.S. is recalling 160 Estrone RIA kits (REF: DSL8700) that may rarely give falsely high patient results, which could cause temporary injury with remote probability.

    Product
    Estrone RIA, REF: DSL8700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2336-2025·2025-08-27

    Estrone diagnostic kits recalled over rare falsely high or low results

    Estrone RIA kits, catalog number DSL8700, are recalled because certain lots may rarely give falsely high or falsely low patient results. 279 units are affected.

    Product
    Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide