Agency classClass IOur severity:Severe FDA (Devices)·Z-2997-2018·Announced 2018-09-26

Ventana ultraView Universal DAB Detection Kit Recalled for Dispenser Defects

Ventana Medical Systems is recalling ultraView Universal 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 the ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500. This product is used for Immunohistochemistry (IHC) for in vitro diagnostic use. The recall involves 14,655 units distributed worldwide.

The recall was initiated because the horseradish peroxidase (HRP) reagent dispensers are leaking and sticking. This defect may result in false negative IHC results. The affected lot numbers are Y25695 and Y22147, with UDI 4015630972173.

Healthcare facilities and users of this product should stop using the affected kits and contact Ventana Medical Systems for further instructions.

The recalled product

Product: ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.
Manufacturer: Ventana Medical Systems Inc
Category: Medical Device — In Vitro Diagnostic
Hazard: false-negative-result
mechanical-defect
Affected units: 14,655

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)

Lot Numbers: Y25695
Y22147
UDI: 4015630972173

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 →

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