Ventana recalls CINtec Histology (250) model 725-4793 IHC kits due to leaking reagent dispensers causing false negative results in lab tests.
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Ventana is recalling its CINtec Histology (250) model 725-4793 IHC kits because leaking reagent dispensers can cause false negative results in lab tests. This affects laboratory users who rely on these kits for accurate diagnostic testing.
The reagent dispensers for horseradish peroxidase (HRP) can leak, which may cause false negative results in immunohistochemistry (IHC) tests. This means lab tests might incorrectly show no disease when it's present, leading to missed diagnoses.
Laboratory users who purchased the CINtec Histology (250) model 725-4793 IHC kits with lot number Y23135 are affected. Pathologists and lab technicians using these kits for diagnostic testing are most at risk of inaccurate results.
Check for the model number 725-4793 on the kit packaging. The lot number Y23135 is associated with this recall. These kits were sold with catalog number 06680011001.
Verify the model number 725-4793 and lot number Y23135 on the kit packaging.
Leaking reagent dispensers in these kits can cause false negative results in immunohistochemistry tests, potentially leading to missed diagnoses.
Look for the model number 725-4793 and lot number Y23135 on the kit packaging. These kits were sold with catalog number 06680011001.
The recall record does not specify a remedy, so contact Ventana Medical Systems for guidance.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-3011-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-3011-2018 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.
