Biofire Filmarray Torch System Base

Recalling firm

Medi'Ray New Zealand Ltd

Product

BIOFIRE FILMARRAY TORCH System Base. [Device]. 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

Reason

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...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-09-25

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/79a2bb66-b5ae-453d-8ba9-61eb3a17de67