Reported Oct 29, 2025 · Ongoing
BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument,…
Becton Dickinson & Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton Dickinson & Co. · 7 Loveton Cir · Sparks, MD · 21152-9212
Is this the product you have?
- BD MAX System, for in vitro diagnostic (IVD) use
- labeled as the following1. BD MAX System, BD MAX Instrument
- Catalog Numbers
44191609441927
- Lot codes and dates
- Catalog Number (Serial Numbers)44191609
- UDI/DI
00382904419165(CT0883CT0636CT0462CT0303CT1217CT0257CT0709CT0786CT0713CT0765CT0668CT0930CT0181CT0564CM0113CM0126CT1319CT0634CT1176CT0910CM0066CT0540CT0138CM0072CM0087CT0534CT0278CM0047CT2365CT0242CM0042CT0558CT0648CT0723CT0855CT1179CT0446CM0125CT0873CT0875CT1369CM0009CT0336CT0879CT1354CT0309CT0739CT1767CT1551CT1320CT1351)441927
- UDI/DI
00382904419271(CR1423ACR0005CR0009CR0003CT0592CR0008CR0941CR0007CM0105CR0705CR0589)
- Amount recalled
- 62 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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