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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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.
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