BD Synapsys Laboratory Informatics System Recalled for Service Credential Compromise
BD is recalling the Synapsys Informatics Solution Version 444150 due to compromised service credentials used by technical support teams. Unauthorized access may compromise data confidentiality, integrity, and system availability.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall addresses a cybersecurity vulnerability with no reported data breaches or patient harm. The risk is precautionary pending credential updates.
Plain-English summary
The BD Synapsys Informatics Solution (Laboratory Solution), Version 444150, Catalog Number 444150, is being recalled by Becton Dickinson & Co. The recall was initiated because product service credentials used by BD technical support teams to access the system were accessed by an unauthorized actor.
Until the compromised service credentials are fully updated and secured, there is a risk that unauthorized individuals may gain access to the system. This access could potentially impact the confidentiality, integrity, and availability of the product and associated data. The system has been distributed worldwide, including to the United States and numerous other countries.
Affected healthcare facilities and laboratories should immediately change their product service credentials and review system access logs for any suspicious activity. Contact your BD representative for assistance with credential updates and security guidance.
The recalled product
- Product
- BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 56
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 No: 444150
- UDI-DI: 00382904441500
- Serial Numbers: JRPN215003AB
- BTDN93800189
- JRPN215003VS
- BTDN938000WP
- BTDN938000XZ
- BTDN93600B4R
- BTDN0160058Z
- BTDN939007WP
- BTDN938000Z3
- BTDN940003G5
- BTDN932008FF
- BTDN94000424
- BTDN940003AV
- BTDN938000WY
- JRPN215003UA
- JRPN215003M8
- BTDN01800017
- JRPN215003V7
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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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