{
  "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": [
    {
      "status": "Terminated",
      "city": "Sparks",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87178",
      "recalling_firm": "Becton Dickinson & Co.",
      "address_1": "7 Loveton Cir",
      "address_2": "N/A",
      "postal_code": "21152-9212",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US nationwide distribution.",
      "recall_number": "Z-0954-2021",
      "product_description": "BioGX SARS-CoV-2 Reagents for BD MAX System  Catalog number (REF) 444213.  In vitro diagnostic.      SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.",
      "product_quantity": "938 kits",
      "reason_for_recall": "Some N1 and N2 master mix pouches packaged within the lots of BioGX SARS-CoV-2 Reagents for BD MAX System may be mislabeled. This could result in a kit containing two pouches of N1 master mix or two pouches of N2 master mix, instead of one pouch of each. If laboratory personnel do not notice that both pouches contain tubes with the same color foil seal and use two of the same tubes, there is a low potential for a false negative SARS-CoV-2 result. A false negative SARS-CoV-2 result could lead to an increased risk of disease progression for the patient and additional spread of SARS-CoV-2 if the patient is not quarantined.",
      "recall_initiation_date": "20210107",
      "center_classification_date": "20210205",
      "termination_date": "20211203",
      "report_date": "20210217",
      "code_info": "Catalog Number: 444213,     Lot Numbers: K20-507, K20-508, K20-509, K20-516, K20-517, K21-020, K21-021.     GTIN Number: 00382904442132"
    }
  ]
}