The Recall Desk

Manufacturer

Diamedix Corporation

7 recalls in our database name Diamedix Corporation as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2018-08-08

Of the 7 recalls from Diamedix Corporation 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.

1–7 of 7

  • LowFDA (Devices)·Z-2574-2018·2018-08-08

    Diamedix EBV Test Kit Recalled for Gel-Like Contaminant

    Diamedix Corporation is recalling 147 units of the Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit due to a gel-like contaminant that may affect product performance.

    Product
    Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-2573-2018·2018-08-08

    Diamedix Is-Mumps IgG Test Kit Recalled for Gel-Like Contaminant

    Diamedix Corporation is recalling 505 units of the Is-Mumps IgG Enzyme Immunoassay Test Kit because a gel-like contaminant may affect product performance.

    Product
    Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-1685-2016·2016-05-25

    Diamedix Is-Mumps IgG Test Kit Recalled Due to Sample Diluent Contamination

    Diamedix Corporation is recalling 697 Is-Mumps IgG Test Kits because a gel-like substance was found in the sample diluent, which could compromise product performance.

    Product
    Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1687-2016·2016-05-25

    Diamedix IgG Test Kits Recalled Due to Gel-Like Substance in Diluent

    Diamedix Corporation is recalling 94 Is-EBV-EA-D and Is-Mumps IgG Test Kits because a gel-like substance was found in the sample diluent, potentially compromising performance.

    Product
    Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1686-2016·2016-05-25

    Diamedix IgG Test Kits Recalled Due to Sample Diluent Contamination

    Diamedix Corporation is recalling 588 EBV-VCA and Mumps IgG test kits because a gel-like substance in the sample diluent could compromise performance.

    Product
    Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0445-2013·2012-12-05

    Diamedix Recalls Is-anti-Sm Test Kits Due to Control Failure

    Diamedix Corporation is recalling 65 Is-anti-Sm Test Kits because the positive control recovered high out of specification.

    Product
    The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results ar
    Category
    Medical Device
    Distribution
    Distributed nationwide