FDA recall record

Becton Dickinson & Co BD Veritor Plus Analyzer - intended to provide rapid test results in recall — FDA Z-0630-2022

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…

Class IIclassification
Z-0630-2022official record ID
Feb 16, 2022report date

Recall record at a glance

Official recordZ-0630-2022
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmBecton Dickinson & Co.
Report dateFeb 16, 2022
Recall initiation dateJan 5, 2022
Quantity126,952 Analyzers Updated:129, 848 Analyzers
LocationSparks, MD, United States

Official product description

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

Why the product was 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.

Distribution information

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.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.

Related recall records

Other records from the same recalling company are shown first when available.