Tosoh recalls specific testosterone test kits that may give false high or low results, causing unnecessary treatments or delayed diagnoses. Affected units include certain lot numbers on specific analyzers.
The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.
Tosoh is recalling specific testosterone test kits that could produce inaccurate results. This might lead to extra tests or incorrect treatments, potentially delaying proper care.
The test cups in the recalled lots produce results lower than expected on the analyzer. This can cause the test to show higher or lower testosterone levels than actual, leading to unnecessary follow-up tests or incorrect treatment decisions.
People who use the recalled testosterone test kits for medical testing. Those with specific lot numbers on the listed analyzers are most at risk.
Check the lot number on the test kit (FX12404, FY12407, FY12406, FZ12408) and the model number (0025204) for the Tosoh AIA System. The product is labeled as 'ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY'.
Look for the lot number on the test kit: FX12404, FY12407, FY12406, or FZ12408.
The test cups in the recalled lots produce results lower than expected on the analyzer, which can cause false high or low testosterone results.
Check the lot number on the test kit: FX12404, FY12407, FY12406, or FZ12408, and ensure it's for the Tosoh AIA System model 0025204.
The recall does not require stopping use immediately; check the lot number to see if your kit is affected.
We’ve drafted a message you can send Tosoh to request your refund or repair — edit it as you like.
Subject: Recall Z-2746-2026 — Tosoh Tosoh Hello, I own a Tosoh that is covered by recall Z-2746-2026 from Tosoh. 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.
