BioFire Diagnostics, LLC 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) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AL, AK, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC, PR