Class 2 Device Recall BD Veritor System Reader

• Date Initiated by Firm: April 03, 2019
• Create Date: May 10, 2019
• Recall Status: Terminated on May 04, 2020
• Recall Number: Z-1314-2019
• Recall Event ID: 82616
• 510(K)Number: K112277
• Product Classification: Devices detecting influenza A, B, and C virus antigens - Product Code PSZ
• Product: BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices; Catalog Number: 256055
• Code Information: Serial Numbers: Serial Number 1801179131J10 1801179119J10 1801179139J10 1801179117J10 1801179110J10 1801179115J10 1801159055J10 1801179120J10 1801159036J10 1801179109J10 1801179095J10 1801179128J10 1801189173J10 1801189181J10 1801189108J10 1801189146J10 1801189140J10 1801189126J10 1801189184J10 1801189159J10 1801179092J10 1801179137J10 1612139044GR0 1801179121J10 1801179124J10 1801179148J10 16102993246N0 1801159030J10 1801189102J10 1801189132J10 1801189166J10 1801169045J10 1801169012J10 1801169057J10 1801169049J10 1801169003J10 1801179155J10 1801179142J10 1710169021HM0 16102993166N0 1801169001J10 1801179096J10 1801179111J10 1801189176J10 1801189177J10 1801189180J10 1801169005J10 1801179094J10 1801179175J10 1801179113J10 1801179125J10 1801189104J10 1801189073J10 1801189082J10 1801169018J10 1801179157J10 1801179162J10 1801179156J10 1801189158J10 1801179105J10 1801179133J10 17122792607S0 1801169048J10 1801189183J10 1801189170J10 1801169051J10 1801169058J10 1801189127J10 1801179141J10 1801189178J10 1801189152J10 1801179144J10 1801179145J10 1603209035660 17121990337S0 1801179149J10 1801179165J10 1801159017J10 1801189106J10 1801179153J10 1801179154J10 1801179112J10 1801179101J10 1801189107J10 1801189168J10 16083090396J0 16083090446J0 16083090476J0 16083090766J0 16083190426J0 16083190656J0 1801189169J10 1801039026J00 1801189135J10 16083190756J0 1801169060J10 1801169056J10 1801169004J10 1801179130J10 1801179098J10 1801179114J10 1801179136J10 1801179134J10 1801179122J10 1703259291H60 1801189116J10 1604209189G80 1801159029J10 1801189063J10 1801189072J10 1801169019J10 1801179147J10 1801189182J10 1801189174J10 1801169050J10 1801169052J10 1801169006J10 1801189151J10 1801189061J10 1801189090J10 1801189167J10 1801189160J10 1801159039J10 1801159047J10
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• Manufacturer Reason for Recall: Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment
• FDA Determined Cause: Under Investigation by firm
• Action: BD notified customers by letter on 4/3/19 via FedX providing problem, health risk and action to take: BD is requesting that customers discard the affected instrument(s) for replacement. BD will replace your affected Veritor instrument(s) upon receipt of the Customer Response Form. BD Customer/Technical Support 800-638-8663 Monday  Friday between 7:00am and 7:00pm (EST) in the United States.For customers outside the US, contact your local BD representative or distributor.
• Quantity in Commerce: 124
• Distribution: Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = PSZ and Original Applicant = Becton, Dickinson and Company