Ventana recalls specific immunohistochemistry kits for false negative results in Helicobacter Pylori testing. Affected lots may cause inaccurate test results.
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Ventana is recalling certain anti-Helicobacter Pylori PAB 250 kits because leaking reagent dispensers could cause false negative results in IHC tests. This means test results might be inaccurate, potentially leading to incorrect diagnoses.
The reagent dispensers may leak or stick, causing false negative results in immunohistochemistry tests. This could lead to incorrect diagnoses of Helicobacter Pylori infections.
Lab technicians and pathologists using the specific Ventana kits for Helicobacter Pylori testing. Those with the affected lot numbers are most at risk.
Check the lot numbers: Y12986, Y16448, Y24119, Y16912Z. The product has catalog number 06425623001 and model 790-1015 for immunohistochemistry testing.
Look for lot numbers Y12986, Y16448, Y24119, or Y16912Z on the product label.
False negative results may occur, which could lead to incorrect diagnoses of Helicobacter Pylori infections.
Check the lot numbers: Y12986, Y16448, Y24119, or Y16912Z. The product has catalog number 06425623001 and model 790-1015.
The recall does not specify a stop-use action; you should check lot numbers to determine if your product is affected.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-3010-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-3010-2018 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.
