BD Synapsys Informatics Solution risks patient data mis-association
The BD Synapsys Informatics Solution may incorrectly associate patient demographic data under specific conditions when the system operates near capacity during rapid manual result processing.
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: This is a FDA Class II recall addressing a risk-of-harm product (patient data integrity in a healthcare system) where no illnesses, injuries, or deaths have been reported. Per the severity rubric, when the hazard is theoretical with no reported harm, the maximum score is 3 (High).
Plain-English summary
The BD Synapsys Informatics Solution (Catalog Number 444150) is a laboratory informatics system manufactured by Becton Dickinson & Co. Approximately 102 systems have been distributed to healthcare facilities in the United States and internationally.
There is a risk that patient demographic data may be mis-associated—linked to the wrong patient record. This risk occurs specifically when laboratory staff use manual result reporting, the Service Control Unit (SCU) operates near capacity, and rapid-processing save actions (Skip, Final Discard, Mark as Read, or Save) are used to process multiple patient results in sequence.
The affected systems are distributed in multiple U.S. states including California, Colorado, Iowa, Illinois, Michigan, Minnesota, Missouri, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Utah, and Wisconsin, as well as in Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
The recalled product
- Product
- BD Synapsys Informatics Solution, Catalog Number 444150
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- patient-data-misassociation
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 (1)
- UDI-DI: 00382904441500
Distribution
Distributed in 15 states:
- CA
- CO
- IA
- IL
- MI
- MN
- MO
- NY
- OH
- OK
- SC
- TN
- TX
- UT
- WI
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