Agency classClass IIOur severity:High FDA (Devices)·Z-0630-2022·Announced 2022-02-16

BD Veritor Plus Analyzer may overheat when using unauthorized power adapter

BD Veritor Plus Analyzer devices may overheat or catch fire if powered with an unauthorized AC adapter instead of the manufacturer-provided one. The recall affects approximately 129,848 analyzers distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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: This is an FDA Class II recall with no reported injuries, deaths, or hospitalizations mentioned in the source. The potential for fire and overheat when using unauthorized power adapters qualifies as a risk-of-harm product where injury has not yet been reported, which per the rubric scores as 3 (High).

Plain-English summary

Becton Dickinson & Co. is recalling the BD Veritor Plus Analyzer, a medical diagnostic device designed to provide rapid test results in clinical and near-patient settings. The recalled analyzers have expiration dates ranging from December 2021 to August 2024.

The devices may overheat and potentially cause fire if powered using an alternative AC power adapter instead of the official adapter provided by Becton Dickinson. The hazard is specific to the use of unauthorized power adapters; the device operates normally when used with the manufacturer-supplied adapter.

Approximately 129,848 analyzers are affected by this recall. The devices have been distributed worldwide, including throughout the United States and to multiple countries such as Canada, Mexico, Australia, China, India, and others.

Healthcare providers and laboratory staff should immediately discontinue use of any non-standard AC power adapters with these devices. Only the official Becton Dickinson-provided adapter should be used to power the analyzer. Affected customers should contact the manufacturer for replacement adapters or further guidance.

The recalled product

Product: BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
Manufacturer: Becton Dickinson & Co.
Category: Medical Device — Diagnostic Testing Equipment
Hazard: fire
overheat

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 (1)

All unexpired analyzers (Exp. Date 12/2021 - 8/2024) UDI: 00382902560661

Distribution

Distributed nationwide across the United States.

Same manufacturer · Becton Dickinson & Co.

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