The Recall Desk

Manufacturer

VISBY MEDICAL INC

1 recall in our database name VISBY MEDICAL INC as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2021-01-20

Of the 1 recalls from VISBY MEDICAL 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.

1–1 of 1

  • ModerateFDA (Devices)·Z-0847-2021·2021-01-20

    Visby Medical Recalls 282 COVID-19 Test Kits for Labeling Errors

    Visby Medical is recalling 282 COVID-19 test kits because some boxes incorrectly state the product is CLIA Waived and some components expire before the kit expiration date.

    Product
    visby medical COVID-19 Test kit *** An in vitro diagnostic for the qualitative detection of SARS-CoV-2 - Product Usage: The Visby Medical COVID-19 Test is only for use under the Food and Drug Administration s Emergency Use Authorization.
    Category
    Medical Device
    Distribution
    Distributed nationwide