BioFire Diagnostics, LLC BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
Brand
BioFire Diagnostics, LLC
Lot Codes / Batch Numbers
if used with the BD BACTEC vials including but not limited to
Products Sold
For BioFire Blood Culture Identification 2 (BDID2) Panel Part Number: RFIT-ASY-0147 UDI-DI code: 00815381020338 Lot Numbers: All non-expired BCID2 Panel lots, if used with the BD BACTEC vials including but not limited to, the bottle types listed in Table 1. NOTE: The affected blood culture vial types most likely contain non-viable Candida tropicalis nucleic acid/DNA fragments that can be detected by the BCID2 Panel. Therefore, all lots of the BioFire BCID2 Panel would be affected if they are used with the affected blood culture vials. Neither the BioFire BCID2 test kits nor the BD BACTEC vials have a defect - both products are performing as intended.
BioFire Diagnostics, LLC is recalling BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medi due to Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
Recommended Action
Per FDA guidance
On 01/26/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via overnight FedEx to customers to inform them of the increased risk of false positive Candida tropicalis results when the BIOFIRE BCID2 Panel is used with BD BACTEC blood culture vials including, but not limited to, the bottle types: BD BACTEC" Lytic Anaerobic medium BD BACTEC" Peds Plus medium BD BACTEC" Plus Aerobic medium BD BACTEC" Plus Anaerobic medium BD BACTEC" Standard Aerobic medium BD BACTEC" Standard Anaerobic medium Customers are requested to take the following actions: - If the BIOFIRE BCID2 Panel is used to test BD BACTEC blood culture vials, positive results for Candida tropicalis should be confirmed by another method prior to reporting the test results. - Distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom they may have transferred the product. - Complete the Acknowledgement Form in Attachment A and return it to bioMerieux so that bioMerieux may acknowledge their receipt of this notification. It is important that they return the acknowledgement form to bioMerieux even if they determine that this urgent field safety notice does not impact their facility. For questions/assistance contact BIOFIRE Technical Support Team at biofiresupport@biomerieux.com or via telephone at 1-800-735-6544 and select option 5.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026