ClearanceBrief
Recall Z-0240-2026 ยท JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

Becton Dickinson & Co.

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.

DateOct 23, 2025 (initiated Sep 23, 2025)
StatusOpen, Classified
ReasonProduct 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.
Root causeSoftware design
ActionBeckton, Dickenson and Company notified consignees on about 09/23/2025 via mailed letter and email. This updated letter serves as a supplement to the original field action communication, dated 10/31/2024. It is intended to clarify that the previously described issue remains unchanged; however, the scope of the impacted product SKUs has been expanded. The update specifically documents additional SKUs including refurbished product codes that were not included in the original communication. Consignees were instructed to follow outlined best practices for maintaining strong security measures to p
Quantity38 units
DistributionWorldwide distribution. US Nationwide including Guam and Puerto Rico, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cambodia, Canada, Chile, China, Colombia, Costa Rica,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.