| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00677-1 |
| Product Name/Description |
BIOFIRE FILMARRAY 2.0 and TORCH System. An in vitro diagnostic medical device (IVD)
FILMARRAY TORCH MODULE BOX
Reference numbers: HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U
FILMARRAY 2.0 INSTRUMENT
Reference numbers: FLM2-ASY-0001, FLM2-ASY-0001-W
Multiple serial numbers.
ARTG 224128
(Biomerieux Australia Pty Ltd - Instrument/analyser IVDs) |
| Recall Action Level |
Sponsor |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
bioMérieux has identified a problem with a subset of internal equipment used during the temperature calibration process on BIOFIRE Torch modules and 2.0 instruments manufactured or serviced between May 2022 and May 2024.
The investigation found that BIOFIRE instruments calibrated with this equipment may report higher melting temperatures (Tms). |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers may continue to their BIOFIRE instruments in accordance with product labelling while waiting for their scheduled temperature calibration.
Customers should review the customer letter for detail instructions regarding actions/ requirements for different panels and to determine which of their instruments are impacted.
If their instrument is not on the impacted list, no action is required.
If their instrument is on the impacted list, it needs to be returned to a BIOFIRE Service Center for recalibration; the local bioMérieux contact will reach out to customers to coordinate the return of their impacted BIOFIRE instrument(s). |
| Contact Information |
1800 333 421 - HELPDESK |