Ventana recalls Basal Cell Cytology Kit (Model 790-1010) due to potential false negative results from leaking reagent dispensers. Affected kits may cause inaccurate cancer tissue tests.
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Ventana is recalling its Basal Cell Cytology Kit (Model 790-1010) because leaking reagent dispensers could cause false negative results in cancer tissue tests. This means the kit might give incorrect results, potentially missing cancer diagnoses.
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 inaccurate cancer tissue analysis if the test is not properly detected.
Pathologists and lab technicians using the kit for cancer tissue testing are most at risk. The recall affects kits purchased with specific catalog numbers and model numbers.
Check for the model number 790-1010 and catalog number 06419445001 on the kit. The recall includes kits with lot number Y20881 and unique device identifier 4015630984534.
Verify the model number 790-1010 and catalog number 06419445001 on the kit label.
Leaking reagent dispensers could cause false negative results in cancer tissue tests, potentially missing cancer diagnoses.
Check for model number 790-1010 and catalog number 06419445001 on the kit. Affected kits have lot number Y20881 and unique device identifier 4015630984534.
The recall does not require immediate stop use; affected kits should be checked for the specific model and catalog numbers.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-3009-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-3009-2018 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.
