Ventana recalls ultraView Universal DAB Detection Kit (part 760-500) due to leaking and sticking reagent dispensers. Affected units have specific lot numbers and UDI codes. Stop using immediately to prevent potential contamination.
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 ultraView Universal DAB Detection Kit because reagent dispensers may leak or stick, especially with horseradish peroxidase and hematoxylin. This could lead to contamination in lab tests if not fixed.
The reagent dispensers may leak or stick when used with horseradish peroxidase (HRP) or hematoxylin II. This could cause contamination in lab samples if the kit is not properly maintained.
Lab technicians and pathologists using the ultraView kit for diagnostic tests are most at risk. The recall affects specific lot numbers and UDI codes.
Check for Ventana part number 760-500 and Roche GMMI 05269806001. Affected units have UDI 04015630984039 and specific lot numbers: Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069, Y22147.
Look for Ventana part number 760-500 and Roche GMMI 05269806001 on the kit.
The recall is due to increased reports of leaking and sticking reagent dispensers, which could lead to contamination in lab tests.
The official notice does not specify a remedy, so contact Ventana directly for guidance.
Affected lot numbers include Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069, Y22147.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-0730-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-0730-2018 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.
