Ventana OptiView Amplification Kit Recalled for Leaking Dispensers
Ventana Medical Systems is recalling OptiView Amplification Kits due to leaking 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 where a false negative diagnostic result is possible, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Ventana Medical Systems Inc is recalling 461 units of the OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099. The affected lot number is Y26282, and the product was distributed worldwide. This kit is used for immunohistochemistry (IHC) in vitro diagnostic testing.
The recall is due to leaking and sticking reagent dispensers for horseradish peroxidase (HRP). This defect may result in false negative IHC results, which could impact diagnostic accuracy.
Healthcare providers and laboratories should stop using the affected units and contact Ventana Medical Systems for instructions on return or replacement.
The recalled product
- Product
- OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 461
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: Y26282
- UDI: 4015630984749
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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