Ventana Basal Cell IHC Reagent Recall Due to Dispenser Defects
Ventana Medical Systems is recalling 75 units of Basal Cell IHC reagents due to leaking and sticking dispensers that may cause false negative 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 75 units of the VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010. This product is an immunohistochemistry (IHC) reagent intended for in vitro diagnostic use. The affected units are identified by Lot Number Y20881 and UDI 4015630984534.
The recall was initiated because the reagent dispensers for horseradish peroxidase (HRP) are leaking and sticking. This mechanical defect may result in false negative IHC results, which could impact diagnostic accuracy.
The affected products were distributed worldwide. Users of this product should stop using the affected units and contact Ventana Medical Systems Inc for further instructions.
The recalled product
- Product
- VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 75
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 Number: Y20881
- UDI: 4015630984534
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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