Ventana recalls iView DAB IHC Detection Kit (part 760-091) due to leaking and sticking reagent dispensers, which may cause inaccurate test results. 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 iView DAB IHC Detection Kit because reagent dispensers can leak or stick, potentially causing inaccurate test results. This affects laboratory users who rely on the kit for diagnostic testing.
The reagent dispensers for horseradish peroxidase (HRP) and Hematoxylin II can leak or stick, leading to inaccurate test results. This may cause incorrect diagnoses if the kit is used for critical medical testing.
Laboratory users who purchased the iView DAB IHC Detection Kit with Ventana part number 760-091 or Roche GMMI 05266157001. Pathologists and lab technicians using the kit for diagnostic tests are most at risk.
Check for Ventana part number 760-091 or Roche GMMI 05266157001 on the kit. Affected units have UDI 04015630971749 and lot numbers Y11834 or Y24245.
Look for Ventana part number 760-091 or Roche GMMI 05266157001 on the kit label.
The reagent dispensers for horseradish peroxidase (HRP) and Hematoxylin II can leak or stick, potentially causing inaccurate test results.
Check for Ventana part number 760-091 or Roche GMMI 05266157001 on the kit. Affected units have UDI 04015630971749 and lot numbers Y11834 or Y24245.
No specific stop-use instruction is provided in the recall notice. However, if you have the affected lot numbers, you should check the kit details to ensure accuracy.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-0731-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-0731-2018 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.
