Ventana recalls Hematoxylin II (part 790-22087) due to leaking and sticking reagent dispensers. Affected users should check product details and contact Ventana for remedy.
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 Hematoxylin II reagent (part number 790-22087) because it leaks and sticks in reagent dispensers. This could cause inaccurate test results or contamination in lab work. Lab users handling these kits should stop using the affected product immediately.
The Hematoxylin II reagent can leak and stick in reagent dispensers, leading to inaccurate test results or contamination of samples. This may cause incorrect diagnoses in cancer and tissue analysis tests.
Lab technicians and pathologists using Hematoxylin II in in vitro diagnostic tests are most at risk. The recall affects users of specific reagent kits for cancer and other tissue analysis.
Check for Ventana Part Number 790-22087 or Roche GMMI 05277965001 on the product label. The product has UDI 04015630972135 and lot numbers Y10759, Y17402, Y21312, Y13938, Y17403, Y22561.
Look for Ventana Part Number 790-22087 or Roche GMMI 05277965001 on the product label.
Reach out to Ventana Medical Systems for instructions on how to handle the recalled product.
The recall indicates increased reports of leaking and sticking reagent dispensers, so it is not safe to use without checking for the specific lot numbers.
Check for Ventana Part Number 790-22087 or Roche GMMI 05277965001 on the label, and look for UDI 04015630972135 with lot numbers Y10759, Y17402, Y21312, Y13938, Y17403, or Y22561.
Contact Ventana Medical Systems for instructions on how to handle the recalled product.
We’ve drafted a message you can send Ventana to request your refund or repair — edit it as you like.
Subject: Recall Z-0738-2018 — Ventana Ventana Hello, I own a Ventana that is covered by recall Z-0738-2018 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.
