Agency classClass IOur severity:Severe FDA (Devices)·Z-0733-2018·Announced 2018-03-07

Ventana ultraView SISH DNP Detection Kit Recalled for Leaking Reagent Dispensers

Ventana Medical Systems is recalling 20 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 source text explicitly identifies the recall as 'Class I' by the FDA. According to the severity rubric, an FDA Class I recall must be scored as 4 (Severe) or higher, regardless of whether specific injuries are reported in the text.

Plain-English summary

Ventana Medical Systems Inc is recalling 20 units of the ultraView SISH DNP Detection Kit US (Ventana Part Number 760-098, Roche GMMI 05572037001). The recall is due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) and Hematoxylin II. These dispensers are components of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit.

The affected units are identified by UDI 04015630970384 and Lot Number Y15146. The product was distributed worldwide, including in the United States, Argentina, Australia, and numerous other countries. The source text does not specify the number of affected units beyond the 20 units listed in the structured data, nor does it report any illnesses or injuries associated with the defect.

Healthcare facilities and users should stop using the affected kits and contact Ventana Medical Systems for further instructions. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death, although no specific injuries are reported in the provided text.

The recalled product

Product: ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
Manufacturer: Ventana Medical Systems Inc
Category: Medical Device — In Vitro Diagnostic
Hazard: leaking
sticking
Affected units: 20

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 04015630970384
Lot Number: Y15146

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.

See all 12 products in this recall →

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Same hazard · leaking