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U.S. Department of Health and Human Services

Class 2 Device Recall BioFire Diagnostics FilmArray Pneumonia Panel plus

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  Class 2 Device Recall BioFire Diagnostics FilmArray Pneumonia Panel plus see related information
Date Initiated by Firm June 07, 2021
Create Date July 08, 2021
Recall Status1 Terminated 3 on July 31, 2023
Recall Number Z-2040-2021
Recall Event ID 88117
510(K)Number K181324  
Product Classification MERS-CoV & common respiratory pathogens semi-quantitative & quantitative multiplex nucleic acid detection syst - Product Code QDS
Product FilmArray Pneumonia Panel plus (Pneumoplus)

Part Numbers:
Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit)
Part No: RFIT-ASY-0142 / UDI: 00815381020321 (6 test kit)
Code Information Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (6 test kit)
Recalling Firm/
Manufacturer		 BioFire Diagnostics, LLC
515 S Colorow Dr
Salt Lake City UT 84108-1248
For Additional Information Contact
800-736-6544 Ext. 5
Manufacturer Reason
for Recall		 Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 06/03/2021, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Notification Letter via overnight FedEx informing its customer that it has identified a potential for obtaining elevated rates of negative adenovirus results when using the pneumonia panel. The potential false negative results are due to a 10-100x reduction in sensitivity specifically for adenovirus species C when using the pneumonia panel kits within 6 months of expiration. In addition: -The test performance is NOT impacted if kits are more than 6 months from expiration date. -Performance for other adenovirus species (e.g. A, B, D, E, F, and G) are NOT affected -The adenovirus assays on all other of the Recalling Firm's Respiratory Panels are NOT affected. Customer are instructed to: 1) Immediately examine their inventory for product identified in this recall. -If the customer identifies any affected Pneumonia Panels in their inventory (i.e. Pneumonia Panels within 6 months of shelf-life), they may continue using the affected product; however, when adenovirus C infection is suspected, negative results for Adenovirus should be confirmed by another method prior to reporting test results to clinicians, or alternatively, the Recalling Firm's Pneumonia Panel Adenovirus negative results should not be reported. 2) If a customer has further distributed this product, they are to identify their customers and notify them at once of this product recall. 3) Complete the enclosed Acknowledgement of Receipt Form as soon as possible and return it to the Recalling Firm via one of the methods listed on the Acknowledgement of Receipt Form - 1) Fill out electronically using the following URL: (https://www.biofiredx.com/pn-5183/) 2) Scan to PDF and return completed form to: recall5183@biofiredx.com Any questions or assistance - contact customer support department at Support@biofiredx.com or via telephone 1-800-735-6544 option 5.
Quantity in Commerce 3,559 kits (Globally)
Distribution U.S.: AK, AL, AZ, CA, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, IN, KS, KY, KY, LA, MA, MD, ME, MI, MI, MN, MO, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY. O.U.S.: Algeria, Angola, Anguilla, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bermuda, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece , Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nicaragua, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, United Arab Emirates, and Vietnam.
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 = QDS and Original Applicant = BioFire Diagnostics, LLC
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