Ventana recalls iView DAB Detection Kit (Model 760-093) for lab use due to leaking reagent dispensers causing false negative IHC results. Affected units have specific lot numbers.
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Ventana is recalling its iView DAB Detection Kit (Model 760-093) for laboratory use because leaking reagent dispensers can cause false negative results in immunohistochemistry tests. This means test results might be inaccurate, potentially leading to incorrect diagnoses.
The reagent dispensers can leak and stick, which may cause false negative results in immunohistochemistry (IHC) tests. This means the test might show a negative result when the sample actually has the target protein, leading to incorrect conclusions.
Laboratory users with the specific Model 760-093 kit (Lot Y19981) are affected. Researchers and pathologists using this kit for immunohistochemistry tests are most at risk.
Check for the Model 760-093 kit with Lot Number Y19981. This kit is for laboratory use only and is part of Ventana's iView DAB Detection Kit series.
Identify the model number (760-093) and lot number (Y19981) on the kit's label to confirm if it's affected.
The recall is for laboratory use only. If the kit has the Model 760-093 and Lot Y19981, it should not be used due to potential false negatives.
The recall does not specify a remedy, so contact Ventana directly for guidance on next steps.
No, the recall states that the leaking dispensers may cause false negative results, so affected kits should not be used.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-3001-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-3001-2018 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.
