| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00643-1 |
| Product Name/Description |
BD Phoenix M50 instrument. An in vitro diagnostic medical device (IVD)
Catalog Number: 443624
All Serial Numbers
ARTG 194808
(Becton Dickinson Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
BD identified through post-market surveillance an increase in the number of complaints for Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix M50 instrument. This problem impacts customers who are using the system for identification. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to:
1. Immediately review the instrument and confirm the software version installed.
2. Complete the Acknowledgement Form in the letter and send back to anz_quality@bd.com stating the software version.
3. BD will book a service visit to provide an update to the PUD (Phoenix update data) and software to correct this problem.
4. Communicate this notification with appropriate members of their facility.
Customer can continue use of the instrument; however, confirmatory testing should be performed on any suspected E. coli misidentifications. |
| Contact Information |
1800 656 100 - Becton Dickinson |