FDA (Devices) recall action 80441
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Contains a gel-like contaminant that may affect 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.
Diamedix Corporation is recalling 505 units of the Is-Mumps IgG Enzyme Immunoassay Test Kit because a gel-like contaminant may affect product performance.
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.