Ventana NEXES VEN IVIEW DAB Detection Kit Recall for Leaking Dispensers
Ventana Medical Systems is recalling NEXES VEN IVIEW DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical diagnostic) where the defect (false negative results) poses a significant risk to patient care, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Ventana Medical Systems Inc is recalling 2,172 units of the NEXES VEN IVIEW DAB Detection Kit, Catalog Number 05266084001, Model 760-041. This product is used for immunohistochemistry (IHC) in vitro diagnostic testing. The recall affects Lot Numbers Y22285 and Y25750, with UDI 4015630970254. The products were distributed worldwide.
The recall is being issued because the horseradish peroxidase (HRP) reagent dispensers are leaking and sticking. This mechanical defect may result in false negative immunohistochemistry results, which could impact diagnostic accuracy.
Healthcare facilities and laboratories should stop using the affected lots immediately. Users should contact Ventana Medical Systems for instructions on returning the product or obtaining replacements.
The recalled product
- Product
- NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Manufacturer
- Ventana Medical Systems Inc
- Affected units
- 2,172
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)
- Lot Numbers: Y22285
- Y25750. UDI: 4015630970254
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 21 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 21 products in this recall →Related recalls
Same manufacturer · Ventana Medical Systems Inc
See all →- ModerateVentana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies
FDA (Devices) · 2026-08-19
- HighMedical Device Recall: Ventana Anti-CD10 Antibody May Produce False Positive Results
FDA (Devices) · 2024-08-28
- HighVENTANA PD-L1 (SP142) Assay kits recalled for light staining causing false-negative results
FDA (Devices) · 2023-01-18
- HighVentana HE 600 Automated Slide Preparer Recalled for Potential Electrical Fire Risk
FDA (Devices) · 2022-07-20
- HighMedical Laboratory Instruments Recalled Due to Electrical Short Circuit Fire Risk
FDA (Devices) · 2022-04-13
Same hazard · false negative result
See all →- HighBioFire Respiratory Panel 2.1 Recalled for Increased False Negative Results
FDA (Devices) · 2026-08-19
- HighVITEK 2 AST-N447 Test Kit Potentially Returns False Resistant Results
FDA (Devices) · 2026-07-15
- HighLuminex VERIGENE Gram Negative Blood Culture Test Recalled
FDA (Devices) · 2025-06-11
- HighVERIGENE Clostridium difficile Nucleic Acid Test May Give False-Negative Results
FDA (Devices) · 2023-07-05
- HighMedical device test system recalled for decreased reactivity and false-negative results
FDA (Devices) · 2022-12-07