Z-0630-2022 Class II Ongoing

Recalled by Becton Dickinson & Co. — Sparks, MD

FDA device recall Z-0630-2022 was initiated by Becton Dickinson & Co. on Jan 5, 2022 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 126,952 Analyzers Updated:129, 848 Analyzers.

Recall Details

Product Type
Devices
Report Date
Feb 16, 2022
Initiation Date
Jan 5, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
126,952 Analyzers Updated:129, 848 Analyzers

Product Description

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

Reason for Recall

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 Pattern

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.

Code Information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0630-2022
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.