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U.S. Department of Health and Human Services

Class 2 Device Recall BioFire Respiratory Panel 2.1 plus Kit

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 Class 2 Device Recall BioFire Respiratory Panel 2.1 plus Kitsee related information
Date Initiated by FirmApril 30, 2025
Date PostedMay 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1877-2025
Recall Event ID 96835
Product Classification Respiratory virus panel nucleic acid assay system - Product Code OCC
ProductBioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Code Information Lot# 1475424/ UDI: None
FEI Number 3002773840
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. 5
Manufacturer Reason
for Recall		Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 in Commerce30 kits
DistributionInternational distribution in the country of Singapore.
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.
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