| TGA Action ID |
RC-2025-RN-00377-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
The BioFire Blood Culture Identification 2 (BCID2) Panel. An in vitro diagnostic medical device (IVD).
REF: RFIT-ASY-0147 (30-pack)
All lot numbers
All unexpired products |
| ARTG Number |
224167 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Following the market actions RC-2023-RN-00943-1 and RC-2024-RN-00110-1, BioMérieux Australia is issuing a Product Correction regarding a mandatory pouch module software update. , This software update will mitigate risks linked to the previous market actions by modifying the analysis parameters (RC-2023-RN-00943-1) and adding an annotation to the customer report (RC-2024-RN-00110-1).
False negative results for blood stream infections may cause delays in accurate results. A false positive result of Candida tropicalis could lead to a patient remaining on inappropriate therapy potentially for three or more days, which could be life-threatening.
In addition to the pouch module software update, the BIOFIRE BCID2 Panel Instructions for Use (IFU) have been updated. |
| Instructions for Customers/Users |
Customers who are affected will receive a notification from BioMérieux Australia regarding the requirement to update the pouch module software for the BIOFIRE BDID2 panel. |
| Action Commencement Date |
4/04/2025 |
| Responsible Entity |
|
| Contact Information |
1800 333 421 - Biomerieux Australia Helpdesk |