BioFire Diagnostics, LLC BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251 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, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251
Brand
BioFire Diagnostics, LLC
Lot Codes / Batch Numbers
REF/UDI-DI: RFIT-ASY-0147/00815381020338. FLM1-PRT-0251-16 and prior.
Products Sold
REF/UDI-DI: RFIT-ASY-0147/00815381020338. FLM1-PRT-0251-16 and prior.
BioFire Diagnostics, LLC is recalling BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular due to Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control pane. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results.
Recommended Action
Per FDA guidance
On 10/17/23, "URGENT: MEDICAL DEVICE CORRECTION" notices were mailed to customers who were asked to do the following: 1) Review a complete list of BIOFIRE Quality Control Materials and references, for Example IQCP Risk Analysis can be found in BIOFIRE QC Tech Note (FLM1-PRT-0251), available from bioMrieux customer support. 2) Assess your Individualized Quality Control Plan (IQCP) and prepare for supplemental C. tropicalis testing if a Candida tropicalis Not Detected result is reported when testing with the MMQCI FilmArray BCID2 Control Panel M416 and/or amend testing plans to include alternate Quality Control materials such as those in FLM1-PRT-0251. 3) Complete and return the via email to recall5788@biomerieux.com Contact customer support at biofiresupport@biomerieux.com or via telephone by dialing 1.800.735.6544 and selecting option 5 for Product Technical Support with any questions or concerns.
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