Class 2 Device Recall BD Veritor Plus Analyzer

• Date Initiated by Firm: January 05, 2022
• Date Posted: February 09, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0630-2022
• Recall Event ID: 89358
• 510(K)Number: K180438
• Product Classification: Devices detecting influenza A, B, and C virus antigens - Product Code PSZ
• Product: BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066
• Code Information: All unexpired analyzers (Exp. Date 12/2021 - 8/2024) UDI: 00382902560661
• FEI Number: 1119779
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: ***UPDATE June 6, 2022**** BD issued a Medical Device Product Advisory letter to Distributors and Users dated July 6, 2022 as a follow-up notification to the voluntary product advisory dated January 5, 2022. In light of this recent complaint, BD is providing additional recommendations to customers to avoid a fire until BD can replace affected units in the field. Letter states: 1. Ensure the contents of this Product Advisory are read and understood by those within your organization. 2. To verify if your BD Veritor" Plus Analyzer(s) is impacted and to complete the acknowledgment distributor response form, you can visit the following website https://go.bd.com/Veritor-Analyzer-Notice.html and enter your serial number(s). 3. AT ALL TIMES USE ONLY the 5V 3A, 15W AC/DC power adapter provided with the BD Veritor" Plus Analyzers. If needed, a replacement AC/DC power adapter (catalog number 445201) can be purchased by calling BD Customer Service. 4. Affix the label(s) provided with this notification to your BD provided AC/DC power adapter(s) to ensure the correct power adapter is always connected to the analyzer(s). BD will contact your account to coordinate replacement of your affected analyzer(s) with expiration dates between December 2021 and August 2024. In the meantime, please implement the recommendations detailed above to mitigate risk of fire. 2. BD will provide credit or replacement for any affected analyzers that are disposed of in response to this notification. ------------------------------------------------------------------------------------------------------------------ BD issued Medical Device Advisory letter dated 1/05/22 to Lab Directors/Risk Managers and Distributors . Letter states reason for recall, health risk and action to take: 1. Ensure the contents of this Product Advisory are read and understood by those within your organization. 2. USE ONLY the AC power adapter provided with the BD Veritor" Plus Analyzers. An image of the AC power adapter provide
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PSZ