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Recall Observatory FDA recall evidence

Device product

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

Z-0630-2022

January 05, 2022

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 89358
Status
Ongoing
Classification
Class II
Quantity
126,952 Analyzers Updated:129, 848 Analyzers
Official record key
device-enforcement:Z-0630-2022

Official wording

Reason: 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.

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.