Medical device manufacturer, BioFire Diagnostics, LLC has issued a medical device safety alert concerning its BioFire FilmArray Pneumonia plus (PN plus) Panel (Part No.: RFIT-ASY-0142 and RFIT-ASY-0143) which is within 6 months of expiration.
According to the manufacturer, it has identified a potential for obtaining elevated rates of false negative Adenovirus results when using the device mentioned above. These false negative results are due to 10-100 times reduction in sensitivity specifically for adenovirus species C when using the mentioned medical device within 6 months of expiration. Affected users should note the following:
The potential impact of a false negative Adenovirus result for mild to moderate illness caused by adenovirus C in immunocompetent patient is serious if the false negative result influences patient care such that the patient remains on or is placed on unnecessary antimicrobial therapy. On the contrary, the overall risk for immunocompromised patients, in particular transplant patients, is critical. A false negative result could lead to increased morbidity and potentially death due to lack of appropriate antiviral therapy.
If the medical device mentioned above is used within 6 months of expiration, affected users should confirm all negative Adenovirus results from patients suspected of adenovirus C infection via another method prior to reporting those results or alternatively, the BioFire PN plus Panel Adenovirus negative result should not be reported.
Affected users are advised to immediately examine their inventory for product mentioned above. If users identify any affected devices, they may continue using the affected product. However when adenovirus C infections is suspected, negative results for Adenovirus should be confirmed by another method prior to reporting test results to clinicians, or alternatively, the BioFire PN plus Panel Adenovirus negative result should not be reported.
According to the local supplier, the products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 15 June 2021