Recall Z-0630-2022— Becton Dickinson & Co.

Name: FDA recall Z-0630-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-05

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2022-01-05. It names one FDA 510(k) clearance: K180438. Product: BD Veritor Plus Analyzer - intended to provide rapid test results in near-patient settings. Catalog Number: 256066. 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..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Ongoing
Initiated: 2022-01-05
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K180438 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBd·cleared 2018-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.