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.
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: 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
- Manufacturer
- Becton Dickinson & Co.
- 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.
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