Ventana recalls iView DAB Detection Kit (model 760-091) due to leaking reagent dispensers causing false negative IHC results. Affected units have lot number Y24245.
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 760-091) 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 for horseradish peroxidase (HRP) can leak and stick, which may cause false negative results in immunohistochemistry tests. False negatives could lead to incorrect diagnoses if the test is used for medical purposes.
Pathologists and lab technicians using the iView DAB Detection Kit for immunohistochemistry tests are most affected. The recall applies to specific lots produced by Ventana.
Check for the model number 760-091 on the kit. Affected units have lot number Y24245 and unique device identifier 4015630971749.
Look for model number 760-091 and lot number Y24245 on the kit packaging or label.
The recalled model is 760-091 for Immunohistochemistry (IHC) in vitro diagnostic use.
Leaking reagent dispensers may cause false negative results in immunohistochemistry tests, potentially leading to incorrect diagnoses.
Check for model number 760-091 and lot number Y24245 on the kit 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-2998-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-2998-2018 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.
