Ventana recalls ultraView SISH DNP Detection Kit (model 800-098) due to leaking reagent dispensers causing false negative IHC results. Affected units sold with lot number Y26299.
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 800-098) because leaking reagent dispensers can cause false negative results in immunohistochemistry tests. This could lead to incorrect test outcomes, especially in medical diagnostics.
The reagent dispensers for horseradish peroxidase (HRP) can leak and stick, which may cause false negative results in immunohistochemistry (IHC) tests. This could lead to incorrect diagnostic conclusions if the test is used for medical purposes.
Pathologists and lab technicians using the ultraView SISH DNP Detection Kit for in vitro diagnostic testing. Those with the specific model and lot number Y26299 are most at risk.
Check for the model number 800-098 and lot number Y26299 on the kit's packaging or label. The product is sold for in vitro diagnostic use in medical laboratories.
Look for the model number 800-098 and lot number Y26299 on the kit's packaging or label.
The recall does not specify if the product is safe to use; it indicates a potential for false negative results due to leaking dispensers.
The recall record does not provide a remedy or action steps for affected products.
Check for the model number 800-098 and lot number Y26299 on the kit's packaging or label.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-3016-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-3016-2018 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.
