The Recall Desk

Manufacturer

Altruan GmbH

3 recalls in our database name Altruan GmbH as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2026-03-18

Of the 3 recalls from Altruan GmbH 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.

1–3 of 3

  • ModerateFDA (Devices)·Z-1559-2026·2026-03-18

    Wondfo Streptococcal A self-test recalled because it lacks FDA clearance

    Altruan GmbH is recalling the Wondfo Streptococcal A At-Home Self-Test, used for group A beta-hemolytic streptococcal infection, because the product is not cleared by the FDA.

    Product
    Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1560-2026·2026-03-18

    Clearest Strep-A cassette test recalled because it lacks FDA clearance

    Altruan GmbH is recalling the Clearest Strep-A Cassette Test, used to detect group A streptococci in throat swab samples, because the product is not cleared by the FDA.

    Product
    Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1561-2026·2026-03-18

    Bisaf Strep A self-test recalled because it lacks FDA clearance

    Altruan GmbH is recalling the Bisaf Strep A Self-Test, used to detect group A streptococcal antigens in throat swabs, because the product is not cleared by the FDA.

    Product
    Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
    Category
    Medical Device
    Distribution
    Distributed nationwide