Ventana recalls specific in vitro diagnostic kits due to leaking and sticking reagent dispensers, which may cause inaccurate test results. Affected kits include NEXES VEN IVIEW DAB DET KT JPN-US EXPORT with part number 760-041.
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 certain in vitro diagnostic kits because they have been reported to leak and stick, which could lead to inaccurate test results. This affects lab users who rely on these kits for horseradish peroxidase and hematoxylin tests.
The dispensers for horseradish peroxidase (HRP) and hematoxylin II in these kits have been reported to leak and stick, potentially causing inaccurate test results. This could lead to incorrect diagnoses if the tests are used without proper results.
Lab technicians and medical professionals using the specific in vitro diagnostic kits for horseradish peroxidase and hematoxylin tests are most at risk. The recall applies to kits sold with the Ventana part number 760-041.
Check for the Ventana part number 760-041 on the kit label. The kit also has a unique device identifier (UDI) of 04015630970254 and lot number Y15392.
Verify the Ventana part number 760-041, UDI 04015630970254, and lot number Y15392 on the kit label.
Ventana is recalling these kits due to increased reports of leaking and sticking reagent dispensers, which could lead to inaccurate test results.
The affected kits include NEXES VEN IVIEW DAB DET KT JPN-US EXPORT with Ventana part number 760-041 and Roche GMMI 05266084001.
Look for the Ventana part number 760-041, UDI 04015630970254, and lot number Y15392 on the kit label.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-0740-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-0740-2018 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.
