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  "name": "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.",
  "description": "FDA recall Z-1139-2024 — BioFire Diagnostics, LLC is recalling 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. (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:MedicalDevice",
    "name": "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.",
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      "name": "BioFire Diagnostics, LLC"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1139-2024/enforcement-record",
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      "name": "FDA recall Z-1139-2024: BioFire Diagnostics, LLC is recalling 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.",
      "text": "The FDA logged enforcement record Z-1139-2024: BioFire Diagnostics, LLC is voluntarily recalling 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. — reason: Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums. Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-26. Affected lots/codes: 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.. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1139-2024 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
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      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
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      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
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      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
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            "Status": "recorded"
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            "Field": "Reason",
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            "Value": "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.",
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution including in the states of  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Andorra, United Arab Emirates, Armenia, Argentina, Austria, Australia, Bosnia, Belgium, Bulgaria, Bahrain, Brunei, Bolivia, Brazil, Canada, Switzerland, Cote D'Ivoire, Chile, China, Colombia, Costa Rica, Cyprus, Cech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgia, Guadeloupe, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Iceland, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Korea, Kuwait, Lebanon, Lithuania, Latvia, Morocco, Macedonia, Mali, Mongolia, Macau, Mexico, Malaysia, New Caledonia, Nigeria, Nicaragua, Netherlands, Norway, New Zealand, Oman, Panama, Peru, French Polynesia, Philippines, Pakistan, Poland, St. Pierre/Miquelon, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, El Salvador, Thailand, Tunisia, Turkey, Taiwan, Uganda, Uruguay, Vatican City, Venezuela, Vietnam, South Africa, and Zimbabwe.",
            "Status": "recorded"
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