Ventana OptiView DAB IHC Detection Kit Recalled for Leaking and Sticking
Ventana Medical Systems is recalling OptiView DAB IHC Detection Kits due to increased reports of leaking and sticking reagent dispensers.
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: "Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II."
Plain-English summary
Ventana Medical Systems Inc is recalling the OptiView DAB IHC Detection Kit (Ventana Part Number 760-700, Roche GMMI 06396500001). The recall involves 12,028 units distributed worldwide, including the United States, Canada, and various countries in Asia, Europe, and South America.
The recall was initiated due to increased reports of leaking and sticking reagent dispensers. These dispensers are components of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit and Hematoxylin II. The specific lot numbers affected are Y19271, Y11625, Y24225, and Y15571.
Users of these in vitro diagnostic devices should stop using the affected kits and contact Ventana Medical Systems for further instructions or replacement.
The recalled product
- Product
- OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 12,028
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 (5)
- UDI 04015630984039
- Lot Numbers: Y19271
- Y11625
- Y24225
- Y15571
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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