The Recall Desk

Manufacturer

Versea Diagnostics LLC

4 recalls in our database name Versea Diagnostics LLC as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2021-09-08

Of the 4 recalls from Versea Diagnostics LLC 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.

1–4 of 4

  • HighFDA (Devices)·Z-2410-2021·2021-09-08

    COVID-19/Flu Rapid Test Distributed to Non-Certified Laboratories

    COVID-19/Flu rapid diagnostic test was distributed to laboratories not certified under federal clinical standards. The 563,290-unit recall affects nationwide distribution; products were authorized only for CLIA-certified laboratories.

    Product
    Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2409-2021·2021-09-08

    Healgen COVID-19 Rapid Test Cassette Recalled Due to Unauthorized Laboratory Distribution

    Healgen COVID-19 IgG/IgM Rapid Test Cassettes were distributed to laboratories not certified under CLIA, violating Emergency Use Authorization requirements. Unauthorized labs may produce inaccurate test results.

    Product
    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2408-2021·2021-09-08

    FaStep COVID-19 Test Devices Recalled for Unauthorized Laboratory Distribution

    Versea Diagnostics recalled 563,290 FaStep COVID-19 antibody test devices that were distributed to laboratories not certified under federal standards. The devices were authorized only for use in CLIA-certified laboratories.

    Product
    FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood. Intended for use as an aid in identifying individuals w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2407-2021·2021-09-08

    COVID-19 diagnostic test distributed outside certified laboratory channels

    CareStart COVID-19 Antigen Rapid Diagnostic Test units were distributed to non-CLIA-certified customers, violating the product's Emergency Use Authorization requirements.

    Product
    CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by thei
    Category
    Medical Device
    Distribution
    Distributed nationwide