BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD
Pending LLM rewrite. Source: FDA_DEVICE Z-0238-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.
- Manufacturer
- Becton Dickinson & Co.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog Number (Serial Numbers): 44191609
- UDI/DI: 00382904419165
- (CT0883
- CT0636
- CT0462
- CT0303
- CT1217
- CT0257
- CT0709
- CT0786
- CT0713
- CT0765
- CT0668
- CT0930
- CT0181
- CT0564
- CM0113
- CM0126
- CT1319
- CT0634
Distribution
Distributed nationwide across the United States.
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