Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37632 |
| Brand Name: | BIOFIRE FILMARRAY TORCH System Base |
| Model: | Ref number - HTFA-ASY 0104, Shipping Configuration No. HTFA ASY-0001 |
| Affected: | All unexpired lots when used with specific BACT/ALERT® Blood Culture Bottles. HTFA-ASY 0104, Shipping Configuration No. HTFA ASY-0001 |
| Software version: | |
| Recalling Organisation: | Medi'Ray New Zealand Ltd 53-55 Paul Matthews Road Albany Auckland 0632 |
| Contact Information: | 0800 633 472 |
| Manufacturer: | BioMerieux - BioFire Diagnostics LLC |
| Issue: | The CAPA investigation found that frequent power cycling of BIOFIRE FILMARRAY TORCH systems can cause degradation of the power switch due to internal arcing, potentially leading to carbon build-up, deformation, and eventual switch failure. Systems with multiple modules may have an increased risk of failure over time if degradation has already occurred. To address this issue, the manufacturer redesigned the power entry module for all BIOFIRE FILMARRAY TORCH System Bases manufactured from 16 September 2024. For units produced before this date, a fused extension cable will be installed to mitigate the risk. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 25/9/2026 |
