The Recall Desk

FDA (Devices) recall action 73694

Diamedix Corporation recalled 3 products on 2016-05-25

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2016-05-25
Critical
0
Units
1,379

Why these products were recalled

A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··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
    Distribution
    26 states
  • ModerateFDA (Devices)··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
    Distribution
    26 states
  • ModerateFDA (Devices)··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
    Distribution
    26 states