Ventana ultraView Universal DAB Detection Kit Recalled for Dispenser Defects
Ventana Medical Systems is recalling ultraView Universal DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where a false negative result could lead to incorrect diagnosis, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Ventana Medical Systems Inc is recalling the ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500. This product is used for Immunohistochemistry (IHC) for in vitro diagnostic use. The recall involves 14,655 units distributed worldwide.
The recall was initiated because the horseradish peroxidase (HRP) reagent dispensers are leaking and sticking. This defect may result in false negative IHC results. The affected lot numbers are Y25695 and Y22147, with UDI 4015630972173.
Healthcare facilities and users of this product should stop using the affected kits and contact Ventana Medical Systems for further instructions.
The recalled product
- Product
- ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 14,655
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot Numbers: Y25695
- Y22147
- UDI: 4015630972173
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 21 recalled by Ventana Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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