Ventana recalls anti-PAN keratin antibody (model 760-2135) due to risk of false negative IHC results from leaking reagent dispensers. Affected lots include Y21610.
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Ventana is recalling a specific antibody product used in lab testing because its reagent dispensers may leak, causing false negative results in cancer tissue tests. This could lead to incorrect diagnoses if the antibody fails to work properly.
The antibody's reagent dispensers may leak, which can cause false negative results in IHC tests. This means cancer tissue samples might be misdiagnosed as healthy when they're actually cancerous.
Lab technicians and pathologists using this antibody for immunohistochemistry (IHC) tests on tissue samples. Those handling the specific lot Y21610 are most at risk.
Check for the model number 760-2135 on the product label. The affected lot number is Y21610. This antibody is sold for in vitro diagnostic use in labs.
Look for the model number 760-2135 and lot number Y21610 on the product label.
The product may cause false negative results if the reagent dispensers leak, but it is not unsafe for normal use. Lab users should check for leaks before use.
The recall does not specify a remedy, so users should check the product label for the model and lot number to determine if it is affected.
Yes, but users should verify the product label to ensure it is not the affected lot Y21610. Leaking dispensers could cause false negatives in tests.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-3003-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-3003-2018 from Ventana. 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.
