FDA Medical Device Recalls (openFDA)
BioFire Diagnostics, LLC: BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- Recall number
- Z-0602-2026
- Recalling firm
- BioFire Diagnostics, LLC
- Product
- BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- Status
- Open, Classified
- Initiated
- 2025-10-22
- Posted
- 2025-11-26
- Terminated
- not on file
- Reason
- Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
- Root cause
- Under Investigation by firm
- Action
- On May 28, 2026, Biomerieux issued a "Urgent: Medical Device Recall" Expansion Notification to affected consignees via E-Mail. Initial notification was sent out on October 22, 2025. Biomerieux asked consignees to take the following actions: 1. 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. Please confirm the quantity of kits that have been destroyed, previously used, or returned 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. 6. Complete and submit the report online. Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
- Quantity
- 97 Kits (2,910 pouches)
- Distribution
- US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
- Lot, serial or model codes
- UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725
- 510(k) numbers
- not on file
- 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