BACTEC FX instruments recalled after service credentials accessed by unauthorized actor
Becton Dickinson is recalling 177 BD BACTEC Blood Culture System instruments after product service credentials used by some technical support teams were accessed by an unauthorized actor.
What this means for you
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 BACTEC Blood Culture System is being recalled, covering the BD BACTEC FX Instrument Top (catalog number 44138509), the remanufactured Instrument Top BACTEC FX (441676) and the BACTEC 9240 System (445569).
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 177 units, 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 BACTEC Blood Culture System, labeled as the following: 1. BD BACTEC FX, Instrument Top, Packaged, Catalog Number: 44138509. 2. Instrument Top Remanufactured Bactec Fx, Catalog Number: 441676. 3. BACTEC 9240 System, Catalog Number: 445569. 4. BD BACTEC FX40 Instrum
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 177
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)
- 1. Catalog Number: 44138509
- UDI/DI: 00382904413859
- Serial Numbers: FT5675
- FT5497
- FT4948
- FT5781
- FT5120
- FT3993
- FT7779
- FT3387
- FT1993
- FT5019
- FT9109
- FT8412
- FT7176
- FT7344
- FT4282
- FT7400
- FT6093
- FT0962
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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