Ventana recalls HPV III Fam 16 Probe (model 800-4295) due to risk of false negative immunohistochemistry results from leaking reagent dispensers. Affected units sold in US with specific catalog number and lot.
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Ventana is recalling its HPV III Fam 16 Probe (model 800-4295) because leaking reagent dispensers could cause false negative results in immunohistochemistry tests. This might lead to incorrect diagnoses if used in medical testing.
The probe's reagent dispensers may leak or stick, causing false negative results in immunohistochemistry tests. This could lead to incorrect diagnoses if the test is used for medical purposes.
Medical labs using this probe for in vitro diagnostic tests are affected. Patients relying on accurate IHC results could be impacted if false negatives occur.
Check for the model number 800-4295 on the probe. The product was sold in the US with catalog number 05278856001 and lot number Y19417.
Verify the model number 800-4295 and catalog number 05278856001 on the probe.
The recall is for potential false negative results in immunohistochemistry tests, not immediate physical danger.
Check for model number 800-4295 and catalog number 05278856001 on the probe. The product was sold in the US with lot number Y19417.
The recall does not specify a remedy, so check with Ventana Medical Systems for further instructions.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-3014-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-3014-2018 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.
