Ventana recalls ultraView SISH Detection Kit (part number 780-001) due to increased reports of leaking and sticking reagent dispensers, which may 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 ultraView SISH Detection Kit (part number 780-001) because it has been reported to leak and stick in reagent dispensers, potentially causing inaccurate lab results. This affects users who rely on this kit for diagnostic testing.
The reagent dispensers in the kit may leak or stick, which could lead to inaccurate lab results. This issue affects horseradish peroxidase (HRP) dispensers and Hematoxylin II, used in specific diagnostic kits.
Lab technicians and medical professionals using the ultraView SISH Detection Kit for diagnostic testing are most at risk. The recall applies to kits purchased with specific part numbers and lot numbers.
Check for the Ventana part number 780-001 or Roche GMMI 05271967001 on the kit. The kit also has a unique device identifier (UDI) 04015630972296 and lot number Y15133.
Look for the Ventana part number 780-001 or Roche GMMI 05271967001 on the kit label.
Ventana is recalling the ultraView SISH Detection Kit due to increased reports of leaking and sticking reagent dispensers, which could affect lab results.
Check the kit for the Ventana part number 780-001 or Roche GMMI 05271967001. If you have it, contact Ventana for more information.
The recall record does not mention a fix or remedy; users should check if they have the affected kit.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-0732-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-0732-2018 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.
