Ventana ISH iView Blue Detection Kit Recalled for Leaking Dispensers
Ventana Medical Systems is recalling 559 units of the ISH iView Blue Detection Kit because the reagent dispensers may leak or stick.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low risk of adverse health consequences. The defect involves mechanical issues (leaking/sticking) rather than direct biological hazards or reported injuries.
Plain-English summary
Ventana Medical Systems Inc is recalling 559 units of the VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092. This product is used for immunohistochemistry (IHC) for in vitro diagnostic purposes. The affected lot numbers are Y15105 and Y22455, with UDI 4015630971930. The products were distributed worldwide.
The recall was initiated because the reagent dispensers for horseradish peroxidase (HRP) may leak or stick. This defect could potentially affect the performance of the diagnostic tests.
Users of this product should stop using the affected kits and contact Ventana Medical Systems Inc for further instructions or a replacement.
The recalled product
- Product
- VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 559
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: Y15105
- Y22455
- UDI: 4015630971930
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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