| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00375-1 |
| Product Name/Description |
BD Multitest 6-Color TBNK CE-IVD. An in vitro diagnostic medical device (IVD).
Catalog Number: 644611
Lot Numbers: 49510, 32674
ARTG 195253
(Becton Dickinson Pty Ltd - CD cell marker (cluster of differentiation) IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
BD reports an increasing trend of complaints for unusual staining pattern, nonspecific aggregates, high background, double positive signal, and/or antibodies contaminated with substance. The investigation detected a damaged component in affected product may affect integrity of stained cells, causing increase in cell debris as shown on SSC vs CD45 positive leukocyte flow cytometry plots, resulting in atypical increase of double positive events on CD3+CD4+ vs CD3+CD8+ and/or CD3-CD16+CD56+ vs CD3-CD19+ plots. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to:
1. Immediately review and quarantine affected inventory.
2. Dispose of affected stock.
3. Upon receipt of acknowledgement form, BD will contact customers to arrange a credit of impacted stock. |
| Contact Information |
1800 656 100 - Becton Dickinson |