Ventana recalls ISH Protease 3 (model 780-4149) for possible false negative IHC results due to leaking reagent dispensers. Affected lots include Y13927, Y18872, Y22569, Y25883. Contact Ventana for details.
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Ventana is recalling its ISH Protease 3 reagent (model 780-4149) because leaking dispensers may cause false negative results in IHC tests. This could lead to incorrect diagnoses if used in medical testing. The recall affects specific lot numbers.
The reagent dispensers for horseradish peroxidase (HRP) can leak, which may cause false negative results in immunohistochemistry (IHC) tests. This could lead to incorrect diagnoses if the reagent is used in medical testing without proper quality control.
Laboratory users and medical professionals who purchased the affected lot numbers of Ventana's ISH Protease 3 reagent for in vitro diagnostics. Those using the reagent for immunohistochemistry tests are most at risk.
Check the lot number on the reagent container: Y13927, Y18872, Y22569, or Y25883. The product is labeled as ISH Protease 3, model 780-4149 for in vitro diagnostic use.
Identify the lot number on the reagent container to determine if it is affected (Y13927, Y18872, Y22569, Y25883).
The recalled reagent is model 780-4149 for immunohistochemistry (IHC) in vitro diagnostic use.
Lot numbers Y13927, Y18872, Y22569, and Y25883 are affected.
Leaking reagent dispensers may cause false negative results in IHC tests, potentially leading to incorrect diagnoses.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-3005-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-3005-2018 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.
