FDA Medical Device Recalls (openFDA)
BioFire Diagnostics, LLC: BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
- Recall number
- Z-1877-2025
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
- Status
- Open, Classified
- Initiated
- 2025-04-30
- Posted
- 2025-05-29
- Terminated
- not on file
- Reason
- Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
- Root cause
- Under Investigation by firm
- Action
- On April 30, 2025, Biomerieux issued a "Urgent Field Safety Notice" to affected consignees via email. Biomerieux asked consignees to take the following actions: 1. Immediately examine your inventory for the lot identified in this field safety notice. 2. Discontinue use and discard any remaining product from this lot in your possession. 3. As previously confirmed discontinued use of product, please confirm the amount of kits destroyed on the attached Acknowledgement of Receipt Form. 4. If you have further distributed this product, please identify any recipients and notify them at once. 5. Please complete the accompanying Acknowledgement of Receipt Form and return to bioMrieux so that bioMrieux may acknowledge your receipt of this notification.
- Quantity
- 30 kits
- Distribution
- International distribution in the country of Singapore.
- Lot, serial or model codes
- Lot# 1475424/ UDI: None
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OCC
- 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