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 Diagnostics, FilmArray Pneumonia Panel

  • 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 Diagnostics, FilmArray Pneumonia Panel see related information
Date Initiated by Firm April 16, 2021
Create Date June 24, 2021
Recall Status1 Terminated 3 on April 02, 2024
Recall Number Z-1944-2021
Recall Event ID 87936
510(K)Number K180966  
Product Classification Lower respiratory microbial nucleic acid detection system - Product Code QBH
Product FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144
Code Information Part Number:RFIT-ASY-0144 UDI: 00815381020178  Kit Lot#: 0938121 Pouch Lot#: 19T621
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information Contact
801-736-6354 Ext. 360
Manufacturer Reason
for Recall		 Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 04/16/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification Letter via email informing its customers of an issue identified in the manufacturing process which might contribute to elevated rates of false positive/false negative results and control failures while using the pneumonia panel. Customer are instructed to: 1) Immediately examine their inventory for product identified in this recall. 2) Discontinue use and discard any remaining product in their possession that is subject to this recall. The Recalling Firm will replace the product at no charge in accordance with its standard limited warranty. 3) Confirm the amount of pouches scrapped (if any) on the attached Acknowledgement of Receipt Form. 4) If the affected products have been further distributed, customers are to identify any recipients and notify them at once of this product recall. 5) Complete the accompanying Field Action Acknowledgment of Receipt Form and return to Recalling Firm so that it may acknowledge their receipt of this notification. For questions or concerns contact Customer Support Department at Support@biofiredx.com or via telephone 1-800-735-6544, option 5 for Product Technical Support.
Quantity in Commerce 9 kits (U.S. only)
Distribution U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = QBH and Original Applicant = BioFire Diagnostics, LLC
-
-