Ventana ultraView SISH Detection Kit Recalled for Leaking Reagent Dispensers
Ventana Medical Systems is recalling 6 units of the ultraView SISH Detection Kit 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 recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a severity score of 4 or higher.
Plain-English summary
Ventana Medical Systems Inc is recalling 6 units of the ultraView SISH Detection Kit (Ventana Part Number 780-001, Roche GMMI 05271967001). The recall is classified as Class I by the U.S. Food and Drug Administration. The affected product is an in vitro diagnostic kit used for medical testing.
The recall was initiated due to increased reports of leaking and sticking reagent dispensers. Specifically, the issue affects the horseradish peroxidase (HRP) dispensers and Hematoxylin II components. These dispensers are part of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit.
The affected units were distributed worldwide, including in the United States, Argentina, Australia, and numerous other countries. The specific lot number for the recalled units is Y15133, and the UDI is 04015630972296. Users of this product should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 6
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 04015630972296
- Lot Number: Y15133
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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