| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00003-1 |
| Product Name/Description |
BD BBL Sensi-Disc. An in vitro diagnostic medical device (IVD)
Multiple Product names, codes and lot numbers
ARTG 197287
(Becton Dickinson Pty Ltd - Antimicrobial susceptibility testing IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
BD confirmed through a recent evaluation of BD BBL Sensi-Disc products that the certain products showed reproducibility, accuracy, and/or Quality Control (QC) failures when tested with Haemophilus spp.
Testing with other bacterial pathogens (where indicated) is not affected. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Users should refrain from conducting AST for H.influenzae with impacted discs. The affected product can be continued to be used with other bacterial pathogens (where indicated).
Users should share this notification with all users within their facility network of the product to ensure they are also aware of this field action.
BD advise that it is not necessary to review previous test results and no additional clinical actions are recommended.
BD is implementing actions to prevent recurrence of the issue, including future lots of BD BBL Sensi-Disc being provided with labelling notifying Customers ‘This Product should not be used for the semi-quantitative in vitro susceptibility testing of Haemophilus influenzae’. |
| Contact Information |
1800 656 100 - Becton Dickinson |