FDA Medical Device Recalls (openFDA)
BioFire Diagnostics, LLC: FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
- Recall number
- Z-1518-2025
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
- Status
- Open, Classified
- Initiated
- 2025-02-27
- Posted
- 2025-04-04
- Terminated
- not on file
- Reason
- Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
- Root cause
- Nonconforming Material/Component
- Action
- On February 28, 2025, Biomerieux issued an "Urgent Field Safety Notice" Recall notification to affected consignees via email. The notice described the product, problem and actions to be taken. Biomerieux asked consignees to take the following actions: " Immediately examine your inventory for the lot identified in this field safety notice. " Discontinue use and discard any remaining product from this lot in your possession. bioMrieux will replace the product at no charge in accordance with our standard limited warranty. " Confirm the amount of pouches scrapped (if any) on the attached Acknowledgement of Receipt Form. " If you have further distributed this product, please identify any recipients and notify them at once. " Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification. If you require additional assistance or have any questions, please contact your local bioMrieux Customer Service representative or call customer service department at 1-800-736-6354.
- Quantity
- 29 kits
- Distribution
- OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
- Lot, serial or model codes
- UDI: 00815381020314/Lot# 0979424
- 510(k) numbers
- ["K181324","K222601","K243222"]
- 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