BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, In

FDA device recall Z-0451-2024 · posted 2023-12-01 · Open, Classified

Recall details

Recalling firm

BioFire Diagnostics, LLC

Reason for recall

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.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

PEN

Quantity affected

32,910

Distribution

Worldwide Distribution: US (nationwide): DE, OH, NY, IL, KY, FL, GA, KS, CA, WI, NC,, AK, PA, MN, ND, IN, AR, CO, UT, TX, AL, NJ, MD, SD, LA, OR, MA, ID, NE, MT, VA, IA, MO, WV, TN, MI, WY, SC, AZ, WA

Date initiated

2023-10-17

Date posted

2023-12-01

Location

Salt Lake City, UT

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