FDA Medical Device Recalls (openFDA)
BioFire Diagnostics, LLC: BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
- Recall number
- Z-2682-2024
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
- Status
- Open, Classified
- Initiated
- 2024-06-10
- Posted
- 2024-08-16
- Terminated
- not on file
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 58
- Distribution
- 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.
- Lot, serial or model codes
- UDI-DI: 00815381020178. Lot/Expiration: 2147623/28-Aug-2024, 2147523/27-Aug-2024
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QDS
- Firm FEI
- 3002773840
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28