Ventana Medical Systems recalls OptiView Amplification Kit (250 tests) due to risk of false negative immunohistochemistry results from leaking reagent dispensers.
Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur.
Ventana Medical Systems is recalling its OptiView Amplification Kit (250 tests) because leaking reagent dispensers could cause false negative results in immunohistochemistry tests. This affects laboratory use where accurate test results are critical.
Leaking reagent dispensers in the OptiView Amplification Kit can cause false negative results in immunohistochemistry (IHC) tests. This means tests might incorrectly show no disease when disease is present, potentially leading to missed diagnoses.
Laboratory users and pathologists who perform immunohistochemistry tests with this kit are most at risk. The recall affects specific lots of the OptiView Amplification Kit.
Check for the model number 860-099 and catalog number 06718663001 on the kit. The affected lot number is Y26282 with UDI 4015630984749.
Verify the model number 860-099 and catalog number 06718663001 on the kit packaging.
Leaking reagent dispensers can cause false negative immunohistochemistry results, meaning tests might incorrectly show no disease when disease is present.
Look for model number 860-099, catalog number 06718663001, and lot number Y26282 with UDI 4015630984749.
The recall record does not specify a remedy, so contact Ventana Medical Systems for guidance.
We’ve drafted a message you can send Ventana Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-3000-2018 — Ventana Medical Systems Ventana Medical Systems Hello, I own a Ventana Medical Systems that is covered by recall Z-3000-2018 from Ventana Medical Systems. 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.
