| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01000-1 |
| Product Name/Description |
BD BACTEC Micro MGIT Calibration Vial.
Lot Number: 2209320, 2067938
Update 3.4.24 - new lot number affected : 3268593
Catalogue Number: 441049
ARTG 194808
(Becton Dickinson Pty Ltd - Instrument/analyser IVDs)
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
BD has determined that the Calibration Vials referenced have a performance issue. The performance issue is due to low fluorescence and/or low media fill.
Incorrect fluorescence level emitted by affected BD BACTEC Micro MGIT can lead to false positive detection of Mycobacteria tuberculosis, which may lead to incorrect diagnosis or inappropriate treatment.
There have been no adverse events associated with this problem. |
| Recall Action |
Recall |
| Recall Action Instructions |
Required actions for users:
1. Immediately review and quarantine inventory for the specific product code and type listed here.
2. Communicate this notification with appropriate members of your facility.
3. Dispose of affected stock
4. Read and understand the preparation of interpretive negative and positive control tubes and the manual read information located on page 3 of the product Instructions For Use (IFU)
5. Upon receipt of the Acknowledgement Form, a BD Associate will contact you to arrange credit of your impacted stock. .
NB: If devices have been safely used, no patient follow up activities are required. |
| Contact Information |
1800 656 100 - Becton Dickinson |