BD MAX instruments recalled after service credentials accessed by unauthorized actor
Becton Dickinson is recalling 62 BD MAX System instruments after product service credentials used by some technical support teams were accessed by an unauthorized actor.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record states unauthorized access may affect the integrity and availability of a diagnostic system and its data, with no injuries reported.
Plain-English summary
The BD MAX System, for in vitro diagnostic use, is being recalled, covering the BD MAX Instrument under catalog numbers 44191609 and 441927.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until those 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 recall covers 62 units carrying UDI/DI 00382904419165, distributed worldwide including nationwide in the United States, Guam and Puerto Rico, and to Algeria, Argentina, Armenia and Australia among other countries. The FDA has classified the action as Class II.
Laboratories operating affected serial numbers should follow BD's instructions.
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.
- Affected units
- 62
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
Part of a larger recall action
This product is one of 6 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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