| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00707-1 |
| Product Name/Description |
FACSDuet Sample Preparation System. An in vitro diagnostic medical device (IVD).
Catalog Number: 662588
Serial numbers: All
ARTG 188752
(Becton Dickinson Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
BD identified through a customer complaint investigation, a specimen volume bias problem with the BD FACSDuet Sample Preparation System when using software version 1.4.1.
When the Multidispense feature is enabled in the BD FACSDuet Sample Preparation System software, and the user is preparing a two-tube assay, the specimen volume dispensed into the first tube will be slightly higher than the specimen volume dispensed into the second tube.
For assays, where absolute counts are calculated using BD Trucount Tubes, an increase in the volume may result in higher-than-expected absolute counts in the first tube compared to the second tube. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to:
1. Identify Software Version installed in BD FACSDuet Sample Preparation System at their facility.
2. Cease use of the BD FACSDuet Sample Preparation System with software version 1.4.1. until the Multidispense feature has been disabled. If not already disabled, customers should refer to the Attachment 2 within the customer letter for instructions on how to disable the BD FACSDuet Sample Preparation System Multidispense feature.
A BD Associate will contact customers to arrange BD mandatory upgrade of their BD FACSDuet Sample Preparation System software to version 1.4.2. |
| Contact Information |
1800 656 100 - Becton Dickinson |