BD Veritor System Reader Recalled for Potential False Test Results
Becton Dickinson is recalling 124 BD Veritor System Readers due to background calibration issues that 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 harm.
Plain-English summary
Becton Dickinson & Co. is recalling 124 units of the BD Veritor System Reader (Catalog Number: 256055). The recall is due to background calibration issues that have the potential to cause false positive or false negative test results.
The affected devices were distributed nationwide and in Canada, Chile, Hong Kong, Japan, and Taiwan. An incorrect test result from the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment.
Consumers and healthcare providers should check their serial numbers against the list provided in the official recall notice. If a device is affected, users should stop using it and contact Becton Dickinson for instructions on replacement or repair.
The recalled product
- Product
- BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 124
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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