—#191328

Product

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

FDA product code: PSZ — Devices Detecting Influenza A, B, And C Virus Antigens
Device class: Class 2
Medical specialty: Microbiology
510(k) numbers: K180438
Affected lot / code info: All unexpired analyzers (Exp. Date 12/2021 - 8/2024) UDI: 00382902560661

Why it 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

***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

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

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.

Timeline

Recall initiated: 2022-01-05
Posted by FDA: 2022-02-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191328. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.