Agency classClass IOur severity:Severe FDA (Devices)·Z-3015-2018·Announced 2018-09-26

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.

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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers. A false negative IHC result may occur."

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
Category: Medical Device — In Vitro Diagnostics
Hazard: false-negative-result
mechanical-defect
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 →

Same manufacturer · Ventana Medical Systems Inc

See all →

Moderate
Ventana Recalls navify Digital Pathology Software Due to Image Metadata Discrepancies
FDA (Devices) · 2026-08-19
High
Medical Device Recall: Ventana Anti-CD10 Antibody May Produce False Positive Results
FDA (Devices) · 2024-08-28
High
VENTANA PD-L1 (SP142) Assay kits recalled for light staining causing false-negative results
FDA (Devices) · 2023-01-18
High
Ventana HE 600 Automated Slide Preparer Recalled for Potential Electrical Fire Risk
FDA (Devices) · 2022-07-20
High
Medical Laboratory Instruments Recalled Due to Electrical Short Circuit Fire Risk
FDA (Devices) · 2022-04-13

Same hazard · false negative result