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Terminated

BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055

FDA Recall Z-1314-2019 · Posted None

Recalling FirmBecton Dickinson & Co.
Recall StatusTerminated
Product CodePSZ
Date Initiated2019-04-03
Date Terminated2020-05-04
Product Quantity124

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.

K112277BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+BBecton, Dickinson and Company · 2011-10-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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