The Recall Desk

Manufacturer

SD Biosensor, Inc.

2 recalls in our database name SD Biosensor, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
2
Most recent
2023-05-31

Of the 2 recalls from SD Biosensor, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (100%) 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

  • SevereFDA (Devices)·Z-1594-2023·2023-05-31

    COVID-19 At-Home Test Kits Recalled for Bacterial Buffer Contamination

    SD Biosensor is recalling 2,712,767 Pilot COVID-19 At-Home Test kits nationwide due to bacterial contamination in the liquid buffer component. Users may notice an odor from affected kits.

    Product
    Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0719-2022·2022-03-23

    Unauthorized COVID-19 Diagnostic Test Kits Imported Without FDA Approval

    SD Biosensor's STANDARD Q COVID-19 Ag Home Test kits were illegally imported without FDA approval, clearance, or authorization. Approximately 400,000 units were distributed nationwide.

    Product
    STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
    Category
    Medical Device
    Distribution
    Distributed nationwide