Diamedix recalls Is-Mumps IgG Enzyme Immunoassay Test Kit (Catalog No. 720-540) due to gel-like contaminant that may affect test accuracy. Affected lots: S0406, expiring 05/31/2018.
Contains a gel-like contaminant that may affect product performance.
Diamedix is recalling its Is-Mumps IgG test kits because they contain a gel-like contaminant that could cause inaccurate results. This affects kits with lot number S0406 that expired May 31, 2018. Users should check their kit's lot number and contact Diamedix if needed.
The test kit contains a gel-like contaminant that may interfere with the test's accuracy. This could lead to incorrect results for mumps infections, but does not cause physical harm or injury.
People who purchased the Diamedix Is-Mumps IgG test kit (Catalog No. 720-540) with lot number S0406, expiring May 31, 2018. Healthcare providers and labs using these kits are most at risk.
Check the kit's lot number on the packaging. The affected lot is S0406, which expires May 31, 2018. This kit is for in vitro diagnostic use only.
Look for the lot number on the test kit packaging; affected kits have lot S0406.
The recall states the kit may affect product performance but does not indicate it causes physical harm. It is safe to use if the lot number is not S0406.
The recall does not specify a remedy, so contact Diamedix directly if you have the affected lot number.
Check the lot number on the packaging; affected kits have lot S0406, expiring 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-2573-2018 — Diamedix Diamedix Hello, I own a Diamedix that is covered by recall Z-2573-2018 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.
