BioFire Diagnostics, LLC: Medical Device Recall in 2025 - (Recall #: Z-1877-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

Product Classification:

Class II

Date Initiated: April 30, 2025

Date Posted: June 4, 2025

Recall Number: Z-1877-2025

Event ID: 96835

Reason for Recall:

Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

Status: Ongoing

Product Quantity: 30 kits

Code Information:

Lot# 1475424/ UDI: None

Distribution Pattern:

International distribution in the country of Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated