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Class 2 Device Recall BioFire Diagnostics FilmArray Pneumonia Panel |
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Date Initiated by Firm |
June 07, 2021 |
Create Date |
July 08, 2021 |
Recall Status1 |
Terminated 3 on July 31, 2023 |
Recall Number |
Z-2039-2021 |
Recall Event ID |
88117 |
510(K)Number |
K180966
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Product Classification |
Lower respiratory microbial nucleic acid detection system - Product Code QBH
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Product |
FilmArray Pneumonia Panel (Pneumo)
Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No: RFIT-ASY-0145 / UDI: 00815381020185 (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
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For Additional Information Contact |
800-736-6544 Ext. 5
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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.
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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 |
4,462 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
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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.
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510(K) Database |
510(K)s with Product Code = QBH and Original Applicant = BioFire Diagnostics, LLC
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