Recall Z-0592-2025— 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: K131331, K040099, K020321. Product: BD Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624. 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- K131331 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML)
- K040099 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
- K020321 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
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 Phoenix M50 Automated Microbiology System Version or Model: 443624 Catalog Number: 443624
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.