Ventana OptiView DAB IHC Detection Kit Recalled for Leaking Dispensers
Ventana Medical Systems is recalling OptiView DAB IHC Detection Kits because leaking dispensers may cause false negative test 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 where a false negative diagnostic result could lead to incorrect medical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ventana Medical Systems Inc is recalling the OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700. This product is used for immunohistochemistry (IHC) for in vitro diagnostic use. The recall involves 11,712 units distributed worldwide.
The recall is due to leaking and sticking reagent dispensers for horseradish peroxidase (HRP). This defect may result in a false negative IHC result. The affected lot numbers are Y25760, E00119, and Y24225, with UDI 4015630984039.
Healthcare facilities and laboratories should stop using the affected kits and contact Ventana Medical Systems Inc for further instructions.
The recalled product
- Product
- OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 11,712
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 (4)
- Lot Numbers: Y25760
- E00119
- Y24225
- UDI: 4015630984039
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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