Ventana OptiView Amplification Kit Recalled for Leaking and Sticking Reagent Dispensers
Ventana Medical Systems is recalling OptiView Amplification Kits due to increased reports of leaking and sticking reagent dispensers.
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 issue involves mechanical defects (leaking/sticking) rather than direct patient harm or contamination.
Plain-English summary
Ventana Medical Systems Inc is recalling 518 units of the OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic. The recall is due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers and with Hematoxylin II.
The affected dispensers are part of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit. The specific lot number for the recalled product is Y19318, and the UDI is 04015630984749.
The product was distributed worldwide, including the US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, and China. Users should stop using the affected kits and contact the manufacturer for instructions.
The recalled product
- Product
- OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 518
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)
- UDI 04015630984749
- Lot Numbers: Y19318
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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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