Ventana recalls CINtec PLUS Cytology Kit (Canada/Japan) due to leaking and sticking reagent dispensers for horseradish peroxidase and hematoxylin. Affected units have specific part numbers and lot codes.
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 the CINtec PLUS Cytology Kit (Canada/Japan) because reagent dispensers may leak or stick, potentially causing inaccurate test results. This affects lab users who rely on the kit for medical diagnostics.
The reagent dispensers for horseradish peroxidase (HRP) and hematoxylin II may leak or stick during use, which could lead to inaccurate test results. This is a technical issue with the dispenser mechanism but does not pose a direct physical hazard.
Pathologists and lab technicians in Canada and Japan who use the CINtec PLUS Cytology Kit are most at risk. The recall targets specific units with the Ventana Part Number 805-100 and Roche GMMI 06889549001.
Check for the Ventana Part Number 805-100 or Roche GMMI 06889549001 on the kit. Affected units have UDI 04015630976287 and lot numbers Y22162 or Y15546.
Verify the Ventana Part Number 805-100, Roche GMMI 06889549001, UDI 04015630976287, and lot numbers Y22162 or Y15546 to confirm if your kit is affected.
Ventana recalls the CINtec PLUS Cytology Kit due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase and hematoxylin II.
Check for the Ventana Part Number 805-100, Roche GMMI 06889549001, UDI 04015630976287, and lot numbers Y22162 or Y15546 on the kit.
The recall does not include a remedy; you should check the kit details to confirm if it is affected and contact Ventana for further guidance.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-0735-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-0735-2018 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.
