Ventana Medical Systems Recalls NEXES VEN IVIEW DAB DET KT JPN-US EXPORT
Ventana Medical Systems is recalling NEXES VEN IVIEW DAB DET KT JPN-US EXPORT in vitro diagnostic kits due to increased reports of leaking and sticking reagent dispensers.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must be at least 4 (Severe).
Plain-English summary
Ventana Medical Systems Inc is recalling NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic kits. The recall involves 3,122 units with UDI 04015630970254 and Lot Number Y15392. The products were distributed worldwide, including the US nationwide and various international locations.
The recall was initiated due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. These dispensers are part of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit, and are also associated with Hematoxylin II. The agency has classified this as a Class I recall.
Healthcare facilities and users of these in vitro diagnostic kits should stop using the affected units and contact Ventana Medical Systems Inc for further instructions on the recall process.
The recalled product
- Product
- NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 3,122
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 04015630970254
- Lot Number: Y15392
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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