Diamedix recalls IgG Enzyme Immunoassay Test Kit (Catalog No. 720-640) due to gel-like contaminant that may affect test accuracy. Affected units include Lot T0006 expiring May 31, 2018.
Contains a gel-like contaminant that may affect product performance.
Diamedix recalls a specific IgG enzyme test kit for in vitro diagnostics because it contains a gel-like contaminant that might cause inaccurate results. This affects test reliability and could lead to incorrect health assessments if used without the contaminant being addressed.
The test kit contains a gel-like contaminant that can interfere with the enzyme immunoassay process. This may cause inaccurate test results, potentially leading to incorrect health assessments if the kit is used without the contaminant being addressed.
Users of the Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit (Catalog No. 720-640) with Lot T0006 expiring May 31, 2018 are affected. Healthcare professionals and labs using this kit for diagnostic testing are most at risk.
Check for the product name 'Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit' and catalog number 720-640. The affected lot number is T0006, which expires May 31, 2018.
Verify the catalog number (720-640) and lot number (T0006) on the test kit packaging.
The recall states the kit contains a gel-like contaminant that may affect product performance, but it does not specify that the kit is unsafe to use. Users should check if they have the affected lot number.
The recall record does not provide a remedy, so there is no specific action required beyond checking if you have the affected lot number.
Check the catalog number (720-640) and lot number (T0006) on the packaging. The kit expires May 31, 2018.
We’ve drafted a message you can send Diamedix to request your refund or repair — edit it as you like.
Subject: Recall Z-2574-2018 — Diamedix Diamedix Hello, I own a Diamedix that is covered by recall Z-2574-2018 from Diamedix. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
