Medical device manufacturer, BioFire Diagnostics, has issued a medical device safety alert concerning its BioFire FilmArray Blood Culture Identification (BCID) Panel [Part No.: RFIT-ASY-0126 and RFIT-ASY-0127] and BioFire Blood Culture Identification 2 (BCID2) Panel [Part No.: RFIT-ASY-0147] used with BD BACTECTM Blood Culture Vials [BD Blood Culture Media Catalog No.: 442023, 442020; Expiration dates: 31 Jul 2021 and 31 Aug 2021]
The manufacturer has identified an increased risk of false positive Pseudomonas aeruginosa (P. aeruginosa) results when the above-mentioned products are used. The most probable cause for this risk is the presence of an increased level of nucleic acid from non-viable P. aeruginosa in BD BACTEC blood culture vials. While the presence of non-viable organism does not compromise the intended function of the blood culture vials (i.e. culturing viable microorganisms), the BCID and BCID2 panels detect nucleic acid from viable and non-viable organisms alike.
The manufacturer advises users to confirm positive P. aeruginosa results with another method prior to reporting if the mentioned panel is used to test BD BACTEC blood culture vials [Catalog No.: 442023, 442020; Expiration dates: 31 Jul 2021 and 31 Aug 2021].
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 29 January 2021