{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Salt Lake City",
      "address_1": "515 S Colorow Dr",
      "reason_for_recall": "Firm identified an issue in the manufacturing process which might contribute to elevated rates of false positive results for HSV-1 while using the ME Panel. Only specific kits are affected.",
      "address_2": "",
      "product_quantity": "1350 pouches",
      "code_info": "ME Panel Kit Lot No.  ME Pouch Lot. No.  Kit Expiration Date  580818                        892018                    4/2/2019  584418                        896018                    4/5/2019    Note - Kits contain a Primer Pill Lot 210318.  The Primer Pill is a freeze dried/lyophilized \"pellet\" that contains all of the primers and buffer used in the PCR1 reaction.",
      "center_classification_date": "20181109",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of:  CA DC, FL, IN, KY, MN, MO, NB, NJ, OH, TX and WI.    International: Canada, Columbia and Mexico",
      "state": "UT",
      "product_description": "-Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel  REF RFIT-ASY-0118  30  For FilmArray systems   LOT  KIT UDI (01)00815381020123  CE 0086 IVD      -Fitment Label (P/N RFIT-LBL-0138)  which identifies the pouch label - FilmArray¿ ME Panel v1.4  LOT  SN  CE 0086  IVD      Product Usage:  The FilmArray Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.",
      "report_date": "20181121",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "BioFire Diagnostics, LLC",
      "recall_number": "Z-0446-2019",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "81197",
      "termination_date": "20210428",
      "more_code_info": "",
      "recall_initiation_date": "20180910",
      "postal_code": "84108-1248",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}