The Recall Desk
HighFDA (Devices)·Z-1313-2019·Announced 2019-05-22

BD Veritor Plus Analyzer Recalled for Potential Test Result Errors

Becton Dickinson & Co. is recalling 32 BD Veritor Plus Analyzers because background calibration issues may cause false positive or negative test 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 injury or misdiagnosis has not yet been reported, fitting the High severity criteria for theoretical risk without confirmed adverse events.

Plain-English summary

Becton Dickinson & Co. is recalling 32 units of the BD Veritor Plus Analyzer, an in-vitro diagnostic device intended for use with the BD Veritor System Test Devices. The recall affects units with specific serial numbers listed in the agency record. The devices were distributed nationwide and in Canada, Chile, Hong Kong, Japan, and Taiwan.

The recall was initiated because background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment.

Consumers and healthcare providers should stop using the affected devices and contact Becton Dickinson & Co. for instructions on return or replacement.

The recalled product

Product
BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
Affected units
32

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Becton Dickinson & Co. 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 2 products in this recall →