BioFire Diagnostics, LLC: Medical Device Recall in 2025 - (Recall #: Z-0602-2026)

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, IVD, REF: 423742 (30 test kit)

Product Classification:

Class II

Date Initiated: October 22, 2025

Date Posted: December 3, 2025

Recall Number: Z-0602-2026

Event ID: 97870

Reason for Recall:

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

Status: Ongoing

Product Quantity: 23 kits (690 pouches)

Code Information:

UDI: 00815381020529 /Lot # 2649724

Distribution Pattern:

US Nationwide distribution in the states of ID, OR, AZ.

Voluntary or Mandated:

Voluntary: Firm initiated