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U.S. Department of Health and Human Services

Class 2 Device Recall Biofire Spotfire Respiratory/Sore Throat Panel

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 Class 2 Device Recall Biofire Spotfire Respiratory/Sore Throat Panelsee related information
Date Initiated by FirmApril 01, 2026
Date PostedMay 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2081-2026
Recall Event ID 98719
510(K)NumberK232954 
Product Classification Multi-target respiratory specimen nucleic acid test including SARS-CoV-2 and other microbial agents - Product Code QOF
ProductBiofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Code Information Lot Number: 2215125/UDI: 00815381020390
FEI Number 3002773840
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information ContactBioFire Diagnostics Customer Support
801-736-6354 Ext. 360
Manufacturer Reason
for Recall		Respiratory/sore throat panel test may result in false negative results and control failures.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 in Commerce2400 pouches
DistributionUS Nationwide distribution in the states of MS, TX MN, VA.
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.
510(K) Database510(K)s with Product Code = QOF
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