Ventana OptiView Amplification Kit Recalled for Leaking Dispensers
Ventana Medical Systems is recalling OptiView Amplification Kits due to leaking dispensers that 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 461 units of the OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099. The affected lot number is Y26282, and the product was distributed worldwide. This kit is used for immunohistochemistry (IHC) in vitro diagnostic testing.
The recall is due to leaking and sticking reagent dispensers for horseradish peroxidase (HRP). This defect may result in false negative IHC results, which could impact diagnostic accuracy.
Healthcare providers and laboratories should stop using the affected units and contact Ventana Medical Systems for instructions on return or replacement.
The recalled product
- Product
- OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 461
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: Y26282
- UDI: 4015630984749
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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