FDA Medical Device Recalls (openFDA)
BioFire Diagnostics, LLC: Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- Recall number
- Z-2081-2026
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
- Status
- Open, Classified
- Initiated
- 2026-04-01
- Posted
- 2026-05-06
- Terminated
- not on file
- Reason
- Respiratory/sore throat panel test may result in false negative results and control failures.
- Root cause
- Under Investigation by firm
- Action
- On April 1, 2026, Biomerieux, issued a "Urgent Medical Device Recall" via E-Mail. Biomerieux ask consignees to take the following actions: In this context, we request that you take the following actions: " Examine your inventory for the lot identified in this recall notice. "Discontinue use and discard any remaining product from this lot in your possession. "Please confirm the quantity of kits that have been destroyed, previously used, or returned 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.
- Quantity
- 2400 pouches
- Distribution
- US Nationwide distribution in the states of MS, TX MN, VA.
- Lot, serial or model codes
- Lot Number: 2215125/UDI: 00815381020390
- 510(k) numbers
- ["K232954"]
- PMA numbers
- not on file
- Product code
- QOF
- 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