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U.S. Department of Health and Human Services

Class 2 Device Recall BIOFIRE FILMARRAY Pneumonia Panel plus

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 Class 2 Device Recall BIOFIRE FILMARRAY Pneumonia Panel plussee related information
Date Initiated by FirmJune 10, 2024
Date PostedAugust 16, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2683-2024
Recall Event ID 94942
Product Classification Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System - Product Code QDS
ProductBIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Code Information UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024
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
801-736-6354
Manufacturer Reason
for Recall		Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 6/10/24, field safety notices were sent to laboratory managers who were informed of the following: Discontinue use and discard any remaining product in your possession. If you have further distributed this product, please identify any recipients, and notify them at once. Complete and return the Acknowledgement of Receipt Form and return via email to usfieldactions@biomerieux.com If you have questions, please contact your firm's local US Commercial Operations. at (800) 682-2666. For non-urgent inquiries, please contact the Technical Support Center by email at BioFireSupport@biomerieux.com. The anticipated turnaround time for email inquiries is 24 - 48 hours during normal business hours.
Quantity in Commerce24 Kits
DistributionWorldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.
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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