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.
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 FDA classified this recall as Class I, which mandates a severity score of at least 4 according to the rubric.
Plain-English summary
Ventana Medical Systems Inc is recalling 5,040 units of the OptiView Amplification Kit (Ventana Part Number 760-099, Roche GMMI 06396518001). The affected units are identified by UDI 04015630983834 and Lot Numbers Y15435, Y19322, and Y22447.
The recall was initiated due to increased reports of leaking and sticking reagent dispensers. This issue affects the horseradish peroxidase (HRP) dispensers, which are components of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit and Hematoxylin II.
The affected products were distributed worldwide, including in the United States, Argentina, Australia, and numerous other countries. The FDA has classified this recall as Class I. Users should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 5,040
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 (4)
- UDI 04015630983834
- Lot Numbers: Y15435
- Y19322
- Y22447
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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