Z-0451-2024Class II

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

Name: Z-0451-2024 BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality...
Creator: BioFire Diagnostics, LLC
Published: 2023-10-17
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2023-10-17 / Open, Classified / root cause: manufacturing process

FDA source

BioFire Diagnostics, LLC began a recall of BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel... on 2023-10-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0451-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-17
Posted: 2023-12-01
Recalling firm: BioFire Diagnostics, LLC
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
Product code: PEN Gram-Negative Bacteria And Associated Resistance Markers
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] Contact customer support at [email protected] or via telephone by dialing 1.800.735.6544 and selecting option 5 for Product Technical Support with any questions or concerns.
Quantity in commerce: 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, NH, OK, HI, MS, DC, VT, CT, NM, RI, ME, NV; and OUS (foreign) to countries of: Algeria, Angola, Armenia, Bahrain, Bolivia, Bosnia- Herzegovina, Brunei, Bulgaria, Costa Rica, Croatia, Cyprus, Dominican Republic, Dutch Antilles, Ecuador, El Salvador, Estonia, Gabon, Georgia, Guam, Guatemala, Honduras, Indonesia, Ireland, Iceland, Israel, Ivory Coast, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Macao, Macedonia, Malaysia, Mali, Mongolia, Morocco, New Zealand, Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Qatar, Romania, Saudi Arabia, Serbia , Slovenia, Tunisia, Uganda, United Arab Emirate, Uruguay, Venezuela, Vietnam, Zimbabwe, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Spain, France, United Kingdom, Greece, India, Italia, Japan, Korea, Netherlands, Poland, Portugal, Sweden, Singapore, Thailand, Turkey, Taiwan, Switzerland, Austria, Denmark, Finland, Germany, Belgium, Hungary, South Africa, Philippines, Norway, Mexico
Product codes and lots: REF/UDI-DI: RFIT-ASY-0147/00815381020338. FLM1-PRT-0251-16 and prior.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0451-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0451-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-01

Product code PEN

K193519Class IIBioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC / cleared 2020-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)