Agency classClass IOur severity:Severe FDA (Devices)·Z-3014-2018·Announced 2018-09-26

Ventana Medical Systems Recalls Leaking HPV III Probe Dispensers

Ventana Medical Systems is recalling 195 units of the INFORM HPV III Fam 16 Probe due to leaking and sticking dispensers that may cause false negative test 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 195 units of the INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295. This product is an immunohistochemistry (IHC) reagent intended for in vitro diagnostic use. The specific lot number is Y19417, and the Unique Device Identifier (UDI) is 4015630972210.

The recall was initiated because the reagent dispensers for horseradish peroxidase (HRP) are leaking and sticking. This mechanical defect can lead to a false negative immunohistochemistry result, which may impact the accuracy of diagnostic testing.

The affected units were distributed worldwide. Healthcare facilities and laboratories that have received this specific lot should stop using the product and contact Ventana Medical Systems for instructions on how to return or dispose of the units.

The recalled product

Product: INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 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: 195

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 Number: Y19417
UDI: 4015630972210

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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