Ventana iView DAB Detection Kit Recalled for Leaking and Sticking Dispensers
Ventana Medical Systems is recalling iView DAB Detection Kits because leaking and sticking dispensers may cause false negative IHC results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low risk of adverse health consequences. The hazard is a functional defect leading to false negative test results, with no reported injuries or illnesses.
Plain-English summary
Ventana Medical Systems Inc is recalling 10 units of the iView DAB Detection Kit w/o Secondary Antibody (Catalog Number 05266173001, Model 760-093). The affected units are identified by Lot Number Y19981 and UDI 4015630970261. The product is intended for laboratory use and 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 immunohistochemistry (IHC) results.
The source text does not specify specific actions for consumers or laboratories, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- iView DAB Detection Kit w/o Secondary Antibody, Catalog Number 05266173001, Model 760-093. For laboratory use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 10
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: Y19981
- UDI: 4015630970261
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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