BioFire Diagnostics, LLC: Medical Device Recall in 2024 - (Recall #: Z-2683-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143

Product Classification:

Class II

Date Initiated: June 10, 2024

Date Posted: August 28, 2024

Recall Number: Z-2683-2024

Event ID: 94942

Reason for Recall:

Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.

Status: Ongoing

Product Quantity: 24 Kits

Code Information:

UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.

Voluntary or Mandated:

Voluntary: Firm initiated