Ventana recalls ultraView SISH DNP Detection Kit (part 800-098) 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 its ultraView SISH DNP Detection Kit because reagent dispensers may leak or stick, potentially causing inaccurate test results. This affects labs using the kit for medical diagnostics.
The reagent dispensers for horseradish peroxidase and hematoxylin may leak or stick, which could lead to inaccurate test results. This is a technical issue with the dispenser mechanism, not a safety hazard that causes injury.
Lab technicians and medical professionals using the ultraView SISH DNP Detection Kit for in vitro diagnostics are most at risk. The recall targets specific lot numbers and part numbers.
Check for Ventana Part Number 800-098 or Roche GMMI 05907136001 on the kit. Affected units also have UDI 04015630972135 and Lot Number Y17990.
Look for Ventana Part Number 800-098, Roche GMMI 05907136001, UDI 04015630972135, and Lot Number Y17990 on the kit.
The recall is due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase and hematoxylin, which could cause inaccurate test results.
The official recall notice does not specify a remedy or action steps beyond checking product details. Contact Ventana for further guidance.
No, the hazard is limited to potential inaccurate test results, not physical injury or safety risks.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-0739-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-0739-2018 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.
