Class 2 Device Recall BIOFIRE Blood Culture Identification 2 (BCID2) Panel

• Date Initiated by Firm: June 19, 2024
• Date Posted: July 31, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2456-2024
• Recall Event ID: 94886
• 510(K)Number: K193519
• Product Classification: Gram-Negative bacteria and associated resistance markers - Product Code PEN
• Product: 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
• Code Information: BCID2 Panel REF: RFIT-ASY-0147, UDI-DI: 00815381020338, All unexpired lots. BACT/ALERT REF/UDI-DI: Lot/Expiration: 410851/03573026596057: 0004101638/3/20/2024, 0004101930/7/28/2024, 0004102026/9/4/2024, 0004102408/2/16/2025 410853/03573026596095: 0004101718/4/24/2024, 0004101790/6/1/2024, 0004101958/8/3/2024, 0004102452/3/3/2025
• Recalling Firm/ Manufacturer: BioFire Diagnostics, LLC; 515 S Colorow Dr; Salt Lake City UT 84108-1248
• For Additional Information Contact: Customer Support Department; 800-736-6354 Ext. 5
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• Action: 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.
• Quantity in Commerce: 42,194 Kits
• Distribution: Worldwide - US Nationwide distribution including in the states of FL, IL, KY, CO, KS, NC, AK, NY, ND, CA, TX, MD, GA, OH, WI, SD, LA, MT, VA, IA, MO, MA, WV, NE, OK, AZ, OR, SC, MI, IN, ID, TN, WA, NM, NJ, AR, AL, MN, NH, NV, PA, WY, MS, CT and the countries of AE, AM, AR, AT, BA, BG, BH, BN, BR, CA, CH, CI, CK, CN, CO, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GA, GB, GE, GR, GT, HR, HU, IL, IN, IQ, IS, IT, JO, JP, KK, KR, KW, LB, LT, LV, MK, MM, MX, MY, NG, NO, NW, OM, PA, PH, PK, PL, PT, QA, RO, RS, SA, SI, TN, TR, TW, UG, UY, VN, WF.
• Total Product Life Cycle: TPLC Device Report

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PEN