Company: Becton Dickinson & Co.
Date of Enforcement Report: 5/22/2019
Class II:
PRODUCT
BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
Recall Number: Z-1313-2019
BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
Recall Number: Z-1314-2019
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
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co. on 5/22/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
US Nationwide and International