Ventana iView DAB IHC Detection Kit Recalled for Leaking and Sticking
Ventana Medical Systems is recalling iView DAB IHC Detection Kits due to increased reports of leaking and sticking reagent dispensers.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text identifies the recall as FDA Class I, which is defined as unlikely to cause adverse health consequences, and no injuries or illnesses are reported.
Plain-English summary
Ventana Medical Systems Inc is recalling 1,980 units of the iView DAB IHC Detection Kit (Ventana part Number 760-091, Roche GMMI 05266157001). The recall involves specific lots identified by UDI 04015630971749 and Lot Numbers Y11834 and Y24245.
The recall was initiated due to increased reports of leaking and sticking reagent dispensers. This issue affects the horseradish peroxidase (HRP) dispensers, which are components of the iView, ultraView, and OptiView detection kits, as well as the CINtec PLUS Cytology Kit and Hematoxylin II.
The affected products were distributed worldwide, including in the United States, Argentina, Australia, and numerous other countries. Users of these in vitro diagnostic kits should check their inventory for the specific lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 1,980
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 (3)
- UDI 04015630971749
- Lot Numbers: Y11834
- Y24245
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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