Ventana recalls OptiView Amplification Kit (part number 760-099) due to leaking and sticking reagent dispensers for horseradish peroxidase and Hematoxylin II. Affected units have specific lot numbers and UDI.
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 OptiView Amplification Kit because reagent dispensers may leak or stick, especially with horseradish peroxidase and Hematoxylin II. This could lead to inaccurate test results in medical diagnostics.
The reagent dispensers in the OptiView kit may leak or stick when used with horseradish peroxidase (HRP) and Hematoxylin II. This can cause inaccurate test results in medical diagnostics, but does not pose a direct physical hazard.
Pathologists and lab technicians using the OptiView Amplification Kit for in vitro diagnostics are most at risk. The recall affects specific lot numbers and units sold with certain part numbers.
Check for Ventana Part Number 760-099, Roche GMMI 06396518001, and lot numbers Y15435, Y19322, or Y22447. The kit has a unique device identifier (UDI) 04015630983834.
Identify the lot numbers Y15435, Y19322, or Y22447 and Ventana Part Number 760-099 on the kit.
Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase and Hematoxylin II in the OptiView Amplification Kit.
The recall record does not specify a remedy, so contact Ventana directly for guidance.
Lot numbers Y15435, Y19322, and Y22447.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-0736-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-0736-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
