BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
FDA Recall Z-1313-2019 · Posted None
Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodePSZ
Date Initiated2019-04-03
Date Terminated2020-05-04
Product Quantity32 units
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
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.
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.