Recall Z-1314-2019 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Becton Dickinson & Co.
BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
| Date | Apr 3, 2019 |
| Status | Terminated |
| Reason | 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 |
| Root 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 | 124 |
| Distribution | Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112277 | BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B Becton, Dickinson and Company, Oct 28, 2011 |