Ventana iView DAB Detection Kit Recalled for Leaking and Sticking Dispensers
Ventana Medical Systems is recalling iView DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative immunohistochemistry 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 device) where a defect may lead to false negative results, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ventana Medical Systems Inc is recalling 3,068 units of the iView DAB Detection Kit (Catalog Number 05266157001, model 760-091). The affected product is an immunohistochemistry (IHC) kit intended for in vitro diagnostic use. The recall involves Lot Number Y24245 with UDI 4015630971749. The product was distributed worldwide.
The recall was initiated because the horseradish peroxidase (HRP) reagent dispensers are leaking and sticking. This defect may result in false negative IHC test results. No specific illnesses or injuries are reported in the source text, but the risk involves diagnostic error.
Healthcare facilities and laboratories should stop using the affected kits and contact Ventana Medical Systems for instructions on return or replacement. Users should verify their lot numbers against the recall information to determine if their inventory is affected.
The recalled product
- Product
- iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 3,068
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: Y24245
- UDI: 4015630971749
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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