Recall Z-2683-2024— BioFire Diagnostics, LLC

Name: FDA recall Z-2683-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-10

Class II · Ongoing

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2024-06-10. FDA's recall record names no specific 510(k) clearance for this event. Product: BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143. Reason: 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..

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-06-10
Firm location: Salt Lake City, UT, United States

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.