FDA-Device2025-10-29Class IIPROCESSING DEFECT

BD MAX System diagnostic instrument recalled for unauthorized access risk to product data

OTHERNationwide distributionMedical devices

What this means

Support service credentials for some BD MAX diagnostic systems were accessed by an unauthorized person. Until BD updates these credentials, there is a risk that someone could gain unauthorized access to the system and the data it contains.

Contact BD technical support for credential updates and security guidance
Do not use affected units until credentials have been updated by BD
Check if your system serial number matches the affected list provided by BD

The agency's original wording

Hazard

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.

Intended for

All ages

Illnesses reported

None reported

Sold states

Worldwide 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, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guatemala, Guinea, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritania, Mauritius, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Sierra Leone, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Timor-Leste, Trinidad and Tobago, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Zambia, and Zimbabwe.

Affected count

62 units

Manufactured in

7 Loveton Cir, Sparks, MD, United States

Products

BD MAX System, for in vitro diagnostic (IVD) use, labeled as the following: 1. BD MAX System, BD MAX Instrument, Catalog Numbers: 44191609, 441927.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0238-2026

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