Device product
BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
Z-0630-2022
Product summary
- 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
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.