BioFire Diagnostics, LLC BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
Brand
BioFire Diagnostics, LLC
Lot Codes / Batch Numbers
UDI-DI: 00815381020178. Lot/Expiration: 2147623/28-Aug-2024, 2147523/27-Aug-2024
Products Sold
UDI-DI: 00815381020178. Lot/Expiration: 2147623/28-Aug-2024, 2147523/27-Aug-2024
BioFire Diagnostics, LLC is recalling BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 6/10/24, field safety notices were sent to laboratory managers who were informed of the following: Discontinue use and discard any remaining product in your possession. If you have further distributed this product, please identify any recipients, and notify them at once. Complete and return the Acknowledgement of Receipt Form and return via email to usfieldactions@biomerieux.com If you have questions, please contact your firm's local US Commercial Operations. at (800) 682-2666. For non-urgent inquiries, please contact the Technical Support Center by email at BioFireSupport@biomerieux.com. The anticipated turnaround time for email inquiries is 24 - 48 hours during normal business hours.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026