Immunotech recalls Estrone RIA kits (DSL8700) with specific serial numbers due to rare risk of false high or low results that could cause temporary or permanent injury. Affected healthcare professionals should check their kit numbers.
Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.
Immunotech recalls certain Estrone RIA diagnostic kits that may rarely produce false high or low test results. This could potentially cause temporary or permanent injury in very rare cases. Healthcare professionals using these kits should stop using affected units and contact Immunotech for details.
The kits may rarely give false high or low results during testing. These errors could lead to temporary or permanent injury in very rare cases, but the issue only occurs in some extremely uncommon situations.
Healthcare professionals using Estrone RIA kits with specific serial numbers (241014D, 241111C, etc.) are affected. Those using the kits for estrone testing in human serum or plasma are most at risk.
Check the kit's serial numbers: 241014D, 241111C, 241209C, 241209D, 250106C, 250106D, or 250203C. The product is an in vitro diagnostic kit for estrone testing used by healthcare professionals.
Look for serial numbers 241014D, 241111C, 241209C, 241209D, 250106C, 250106D, or 250203C on the kit.
Estrone RIA is an in vitro diagnostic kit for measuring estrone in human serum and plasma.
Serial numbers 241014D, 241111C, 241209C, 241209D, 250106C, 250106D, and 250203C.
The recall record does not specify a remedy, so contact Immunotech directly for instructions.
We’ve drafted a message you can send Immunotech to request your refund or repair — edit it as you like.
Subject: Recall Z-2336-2025 — Immunotech Immunotech Hello, I own a Immunotech that is covered by recall Z-2336-2025 from Immunotech. 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.