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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur."
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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