Agency classClass IOur severity:Severe FDA (Devices)·Z-0730-2018·Announced 2018-03-07

Ventana ultraView Universal DAB Detection Kit Recalled for Leaking Reagent Dispensers

Ventana Medical Systems is recalling ultraView Universal DAB Detection 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 source text explicitly identifies this as an FDA Class I recall. According to the severity rubric, an FDA Class I recall is classified as Severe (score 4) or Critical (score 5). Since no fatalities or serious injuries are reported in the text, the score is 4.

Plain-English summary

Ventana Medical Systems Inc is recalling 72,730 units of the ultraView Universal DAB Detection Kit (Ventana part Number 760-500, Roche GMMI 05269806001). The recall is being conducted by the U.S. Food and Drug Administration (FDA) as a Class I recall.

The recall was initiated due to increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers and with Hematoxylin II. These dispensers are components of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit.

The affected products were distributed worldwide, including in the United States, Argentina, Australia, and numerous other countries. The specific lot numbers involved are Y09284, Y15384, Y18099, Y22153, Y11687, Y17984, Y19302, Y11716, Y18069, and Y22147. The UDI for the product is 04015630984039. Users should contact Ventana Medical Systems Inc for further instructions on how to handle the recalled devices.

The recalled product

Product: ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
Manufacturer: Ventana Medical Systems Inc
Category: Medical Device — In Vitro Diagnostic
Hazard: leaking
sticking
Affected units: 72,730

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 (11)

UDI 04015630984039
Lot Numbers: Y09284
Y15384
Y18099
Y22153
Y11687
Y17984
Y19302
Y11716
Y18069
Y22147

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