Ventana iVIEW Blue Plus Detection Kit Recalled for Dispenser Leaks
Ventana Medical Systems is recalling iVIEW Blue Plus Detection Kits because leaking dispensers 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 injury has not yet been reported, but the defect may lead to false negative diagnostic results.
Plain-English summary
Ventana Medical Systems Inc is recalling the ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097. The recall involves 2,136 units distributed worldwide. The affected lot numbers are Y15410 and Y24365, with UDI 4015630972029.
The recall is due to leaking and sticking reagent dispensers for horseradish peroxidase (HRP). This defect may result in false negative immunohistochemistry (IHC) test results. The product is intended for in vitro diagnostic use.
Users of this product should stop using the affected kits and contact Ventana Medical Systems for further instructions.
The recalled product
- Product
- ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 2,136
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 (2)
- Lot Numbers: Y15410
- Y24365 UDI: 4015630972029
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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