FDAClass IIFebruary 16, 2022

BD Veritor Plus Analyzer - intended to provide rapid recall

BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066

Why was BD Veritor Plus Analyzer - intended to provide rapid recalled?

May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
Recalling firm
Becton Dickinson & Co.
Quantity
126,952 Analyzers Updated:129, 848 Analyzers
Distribution
Worldwide distribution - US Nationwide and the countries of Armenia, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, Fiji, Guatemala, Hong Kong, Honduras, Haiti, Indonesia, India, Jamaica, Cambodia, South Korea, Macao, Mexico, New Zealand, Panama, Peru, Philippines, Singapore, El Salvador, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Vietnam.
Recall date
February 16, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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