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.
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 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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