Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall BioFire Respiratory Panel 2.1

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall BioFire Respiratory Panel 2.1see related information
Date Initiated by FirmOctober 22, 2025
Date PostedNovember 26, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0602-2026
Recall Event ID 97870
Product Classification Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents - Product Code QOF
ProductBioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Code Information UDI: 00815381020529 /Lot # 2649724
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information ContactCustomer Support Department
1800-736-6354 Ext. 360
Manufacturer Reason
for Recall		Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn October 22, 2025, Biomerieux issued a "Urgent: Medical Device Recall" Notification to affected consignees via E-Mail. 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 in Commerce23 kits (690 pouches)
DistributionUS Nationwide distribution in the states of ID, OR, AZ.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-