Ventana recalls OptiView Amplification Kit (250 Test) 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 OptiView Amplification Kit (250 Test) because reagent dispensers may leak or stick, potentially causing inaccurate test results. This affects laboratory users who rely on these kits for in vitro diagnostics.
The reagent dispensers in the OptiView Amplification Kit may leak or stick, which could lead to inaccurate test results. This issue affects horseradish peroxidase (HRP) dispensers and Hematoxylin II in specific diagnostic kits.
Laboratory users who purchased the OptiView Amplification Kit (250 Test) with Ventana Part Number 860-099 or Roche GMMI 06718663001 are most at risk. The hazard is specific to reagent dispensers in certain diagnostic kits.
Check for Ventana Part Number 860-099 or Roche GMMI 06718663001 on the kit. Affected units have UDI 04015630984749 and Lot Number Y19318.
Verify the Ventana Part Number 860-099 or Roche GMMI 06718663001 on the kit label.
The recall is due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase and hematoxylin in the OptiView Amplification Kit.
Check for Ventana Part Number 860-099 or Roche GMMI 06718663001 on the kit. Affected units have UDI 04015630984749 and Lot Number Y19318.
The recall record does not specify a remedy, so no action is required beyond checking if your kit matches the affected details.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-0737-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-0737-2018 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.