Ventana ultraView SISH DNP Detection Kit Recalled for Leaking Reagent Dispensers
Ventana Medical Systems Inc is recalling 358 units of the ultraView SISH DNP Detection Kit 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 hazard is a mechanical defect (leaking/sticking) in a laboratory diagnostic kit, which does not pose a direct safety threat to patients or users in the same manner as a contaminated food or a defective medical implant.
Plain-English summary
Ventana Medical Systems Inc is recalling 358 units of the ultraView SISH DNP Detection Kit, identified by Ventana Part Number 800-098 and Roche GMMI 05907136001. The specific lot number is Y17990, and the UDI is 04015630972135. The product is an in vitro diagnostic device.
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 issue involves the physical integrity of the dispensing mechanism rather than a biological contamination or diagnostic accuracy failure.
The affected products were distributed worldwide, including in the US, Argentina, Australia, and numerous other countries. Users of these kits should check their inventory for the specific lot number and part number listed above. If the product matches the recalled description, users should stop using the affected dispensers and contact the manufacturer for instructions on replacement or return.
The recalled product
- Product
- ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
- Manufacturer
- Ventana Medical Systems Inc
- Hazard
- Affected units
- 358
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 04015630972135
- Lot Number: Y17990
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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