Ventana ultraView SISH DNP Detection Kit Recalled for Leaking Dispensers
Ventana Medical Systems is recalling 342 units of the ultraView SISH DNP Detection Kit because leaking dispensers 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 (false negative diagnostic results) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Ventana Medical Systems Inc is recalling 342 units of the ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098. The product is an immunohistochemistry (IHC) kit intended for in vitro diagnostic use. The recall covers Lot Number Y26299 with UDI 4015630972500, which was distributed worldwide.
The recall was initiated due to leaking and sticking reagent dispensers for horseradish peroxidase (HRP). This defect may result in false negative IHC results. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and users should stop using the affected units and contact Ventana Medical Systems Inc for further instructions on returns or replacements.
The recalled product
- Product
- ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 342
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: Y26299
- UDI: 4015630972500
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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