BD Synapsys Laboratory Software Recalled for Incorrect Test Order Association
Becton Dickinson is recalling BD Synapsys version 2.1 because it allowed test orders to be associated with incorrect culture records.
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: The recall involves a risk-of-harm product (medical device software) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Becton Dickinson & Co. is recalling BD Synapsys Laboratory Solutions, version 2.1, catalog number 444150. The software is a laboratory solution that provides data management and workflow management functionality across clinical diagnostic activities.
The recall was initiated because the software allowed the potential for a test order to be associated with an incorrect culture record. This defect could impact the accuracy of clinical diagnostic data.
The recall affects five sites with distribution in the United States (Ohio, Illinois, Missouri, Tennessee) and the Netherlands. Users of this software should contact Becton Dickinson for further instructions on how to proceed.
The recalled product
- Product
- BD Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data…
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 5
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)
- BD Synapsys version 2.1 UDI: 00382904441500
Distribution
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