Ventana ISH Protease 3 Reagent Recall for Leaking and Sticking Dispensers
Ventana Medical Systems is recalling ISH Protease 3 reagents due to leaking and sticking 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 diagnostic) where injury has not yet been reported, but the defect may lead to false negative results, fitting the High severity criteria.
Plain-English summary
Ventana Medical Systems Inc is recalling ISH Protease 3 (Catalog Number 05273331001, model 780-4149) for immunohistochemistry (IHC) in vitro diagnostic use. The recall involves 2,231 units distributed worldwide.
The recall is due to leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. This defect may result in false negative IHC results.
Affected lot numbers are Y13927, Y18872, Y22569, and Y25883. The UDI is 4015630971886. Users should stop using the affected product and contact Ventana Medical Systems for further instructions.
The recalled product
- Product
- ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 2,231
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 (5)
- Lot Numbers: Y13927
- Y18872
- Y22569
- Y25883
- UDI: 4015630971886
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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