Recall Z-0590-2025— Becton Dickinson & Co.
Class II · Ongoing
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2024-10-31. It names 3 FDA 510(k) clearances: K130470, K120138, K111860. Product: BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916. Reason: BD confirmed that 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..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-31
- Firm location
- Sparks, MD, United States
510(k) clearances named in this recall
3 on FDA's record- K130470 — BD MAX CDIFF ASSAY, BD MAX INSTRUMENT
- K120138 — BD MAX MRSA ASSAY, BD MAX INSTRUMENT
- K111860 — BD MAX GBS ASSAY, BD MAX INSTRUMENT
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
Reason for recall
BD confirmed that 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.