Ventana recalls ultraView SISH DNP Detection Kit model 760-098 for possible false negative IHC results due to leaking reagent dispensers. This kit is used for in vitro diagnostics.
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Ventana is recalling its ultraView SISH DNP Detection Kit (model 760-098) because leaking reagent dispensers could cause false negative results in immunohistochemistry tests. This affects laboratory users who rely on accurate diagnostic testing.
Leaking reagent dispensers in the kit can lead to false negative results in immunohistochemistry tests. This means test results might incorrectly show no disease when disease is present, potentially affecting diagnosis.
Laboratory professionals using this kit for in vitro diagnostics are most at risk. The recall applies to kits with lot number Y24347 and UDI 4015630970384.
Check for the model number 760-098 on the kit. The recall includes kits with lot number Y24347 and unique device identifier 4015630970384.
Look for the model number 760-098 and lot number Y24347 on the kit.
The recall is due to leaking reagent dispensers that can cause false negative results in immunohistochemistry tests.
False negative results may occur, meaning tests could incorrectly show no disease when disease is present.
Check for model number 760-098, lot number Y24347, and unique device identifier 4015630970384.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-2999-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-2999-2018 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.
