Becton Dickinson & Co.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
BD Veritor Connect Software, labeled as the following: 1. Veritor (NUC), Catalog Number: 444881. Transfers in vitro diagnostic results data on the BD Veritor Plus Analyzer to BD Synapsys.
Catalog Number (Serial Numbers): 444881, UDI/DI: 00382904448813, (SL00087, SL00098, SL01320, SL00083, SL00089, SL01002, SL01050, SL01522, SL00095, SL01480, SL01000, SL00551, SL01007, SL00062, SL01354, SL00097, SL01028, SL00066, SL00077, SL00084, SL00074, SL01080, SL00088, SL01038, SL01194, SL00106, SL01003, SL00108, SL00061, SL00073, SL01521, SL01081, 1022, SL00105, SL01033, SL01119, SL01018, SL00080).
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →