{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "167368",
      "product_res_number": "Z-0296-2019",
      "event_date_initiated": "2018-09-05",
      "event_date_posted": "2018-10-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2021-03-22",
      "res_event_number": "81060",
      "product_code": "PAM",
      "k_numbers": [
        "K130914",
        "K143171",
        "K160457",
        "K181493"
      ],
      "product_description": "FilmArray Blood Culture Identification (BCID),  IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI:\nRFIT-ASY-0126 (30 test kit)/ 00815381020086,\nRFIT-ASY-0127 (6 test kit)/ 00815381020093,\n\nwhen used with the following blood culture bottles: Bottle Description/Part Number:\nBACT/ALERT FA Plus/ 410851,\nBACT/ALERT FN Plus/ 410852,\nBACT/ALERT PF Plus/ 410853,",
      "code_info": "All lots.",
      "firm_fei_number": "3002773840",
      "recalling_firm": "BioFire Diagnostics, LLC",
      "address_1": "515 S Colorow Dr",
      "city": "Salt Lake City",
      "state": "UT",
      "postal_code": "84108-1248",
      "additional_info_contact": "800-735-6544 Ext. 5",
      "reason_for_recall": "Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.",
      "root_cause_description": "Material/Component Contamination",
      "action": "On 09/05/2018 the firm sent an Urgent Customer Advisory Notice to all customers via Federal Express (to US customers) and USPS (to Laboratory Directors for all organizations that have ordered kits) informing them that the firm has identified an increased risk of false positive Proteus results when the BioFire BCID Panel is used with BACT/ALERT Blood Culture Bottles:\nBACT/ALERT Blood\nCulture Bottle Catalog No.    Description\n410851                                     BACT/ALERT FA Plus\n410852                                     BACT/ALERT FN Plus\n410853                                     BACT/ALERT PF Plus\n\nwith expiration dates of 2019-05-02 and beyond. The intended function of BACT/ALERT blood culture bottles (culturing viable microorganisms) is not compromised by this anomaly.\n\nBACT/ALERT PF Plus Blood Culture Bottles are included in this notification since they share the same lots of some raw materials used to manufacture implicated lots of BACT/ALERT FA Plus and FN Plus Blood Culture Bottles; there are currently no customer complaints regarding this issue for this bottle type. It is unknown if subsequent lots of BACT/ALERT media will also be subject to this risk; however, BioFire and BioMrieux teams are coordinating efforts to resolve this issue.\n\nThe most probable cause for this risk is the presence of an increased level of nucleic acid from non-viable Proteus in BACT/ALERT Blood Culture Bottles (Table 1). BioFire has confirmed the presence of Proteus nucleic acid in BacT/ALERT bottle lots using an independent PCR/bi-directional sequencing method. The presence of non-viable organism does not compromise the intended function of the blood culture bottles (culturing viable microorganisms). However, the BioFire BCID Panel detects nucleic acid from viable and non-viable organisms alike. Observed false positives are typically seen as multiple positives with the BioFire BCID Panel because a positive culture is a prerequisite to a BCID test.\n\nB",
      "product_quantity": "18038",
      "distribution_pattern": "Worldwide distribution.  US nationwide,  Kuwait, Lebanon, Malaysia, Myanmar, Nicaragua, Oman, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Slovenia, Uruguay, United Arab Emirates, Vietnam",
      "openfda": {
        "k_number": [
          "K152470",
          "K181663",
          "K122514",
          "K243490",
          "K254194",
          "K163390",
          "DEN120014"
        ],
        "registration_number": [
          "3006028115",
          "3002773840",
          "3010749841",
          "3008632402"
        ],
        "fei_number": [
          "3006028115",
          "3002773840",
          "3010749841",
          "3008632402"
        ],
        "device_name": "Gram-Positive Bacteria And Their Resistance Markers",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3365",
        "device_class": "2"
      }
    }
  ]
}