Ventana ISH iView Blue Detection Kit Recalled for Leaking Dispensers
Ventana Medical Systems is recalling 559 units of the ISH iView Blue Detection Kit because the reagent dispensers may leak or stick.
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"
Plain-English summary
Ventana Medical Systems Inc is recalling 559 units of the VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092. This product is used for immunohistochemistry (IHC) for in vitro diagnostic purposes. The affected lot numbers are Y15105 and Y22455, with UDI 4015630971930. The products were distributed worldwide.
The recall was initiated because the reagent dispensers for horseradish peroxidase (HRP) may leak or stick. This defect could potentially affect the performance of the diagnostic tests.
Users of this product should stop using the affected kits and contact Ventana Medical Systems Inc for further instructions or a replacement.
The recalled product
- Product
- VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 559
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 (3)
- Lot Numbers: Y15105
- Y22455
- UDI: 4015630971930
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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