Ventana recalls CINtec PLUS Cytology Kit (CE-IVD) due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase and Hematoxylin II, which could affect lab results.
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.
Ventana is recalling its CINtec PLUS Cytology Kit because reagent dispensers may leak or stick, potentially causing inaccurate lab results. This affects users who rely on the kit for medical testing.
The reagent dispensers for horseradish peroxidase and Hematoxylin II may leak or stick, which could lead to inaccurate lab results. This is a technical issue with the dispenser mechanism, not a safety hazard.
Pathologists and lab technicians using the CINtec PLUS Cytology Kit for medical testing are most at risk. The recall applies to specific lot numbers and part numbers.
Check for Ventana Part Number 605-100 or Roche GMMI 06889565001 on the kit. The recall includes specific lot numbers: Y14122 and Y18107.
Look for Ventana Part Number 605-100 or Roche GMMI 06889565001 on the kit label.
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase and Hematoxylin II could lead to inaccurate lab results.
Check the product details to see if it's affected; the recall applies to specific lot numbers and part numbers.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-0734-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-0734-2018 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.
