BioFire Diagnostics, LLC BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853 Recall

Check Your Product

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

Reason for Recall

As stated by FDA

If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.

Recommended Action

Per FDA guidance

On 06/19/24, recall notices were distributed to laboratory managers who were informed the following: 1) Positive results for Serratia marcescens should be confirmed by another method prior to reporting the test results. 2) Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, post this letter in or near the laboratory, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. 3) Complete and return the acknowledgement form via email to usfieldactions@biomerieux.com If you require additional assistance or have any questions, please contact firm's US Commercial Operations. at (800) 682-2666. For non-urgent inquiries, please contact the Technical Support Center by email at BioFireSupport@biomerieux.com. The anticipated turnaround time for email inquiries is 24 - 48 hours during normal business hours. On 11/04/24, additional notices were sent to customers informing them of three additional affected lots. On 2/3/2025, additional notices were sent to customers informing them of one additional affected lot. On 6/3/2025, additional notices were sent to customers informing them of five additional affected lots.