| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00829-1 |
| Product Name/Description |
BD Synapsys Informatics Solution. An in vitro diagnostic medical device (IVD).
Software version 5.30 and below
Catalog Number: 444150
ARTG 222680
(Becton Dickinson Pty Ltd - Laboratory information system IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
BD identified that for BD Kiestra customers with BD Synapsys running Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilising the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST.
This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. This may result in either a false susceptible or false resistant result.
There has been no adverse event worldwide related to this problem. Currently there are no Australian Customers using this feature. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers should immediately identify if they have the affected software version. The customer letter explains how to find if they have this software.
If the feature is active in their system, they should refer to the attachment in the customer letter for System settings breakpoint feature instructions.
If the inline breakpoint feature is enabled, customers should disable the feature and keep disabled until upgraded to Synapsys software version 5.31 or later.
Customers can contact their BD representative if you require assistance with this process.
It is recommended that users review results from the past 4 weeks to ensure that breakpoints have not been inappropriately utilised in susceptibility determinations |
| Contact Information |
1800 656 100 - Becton Dickinson |