{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Sparks",
      "address_1": "BD Diagnostic Systems",
      "reason_for_recall": "The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert:    One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab), produced negative results with the BD MAX MRSA Assay.    One of the samples tested with each of the CAP surveys MRS5-A 2014 and MRS5-B 2014 yielded false positive results.",
      "address_2": "7 Loveton Circle",
      "product_quantity": "585,048 tests",
      "code_info": "All Lots with the expiration date January 21, 2014 or later",
      "center_classification_date": "20140910",
      "distribution_pattern": "US Distribution including the states of : CA, FL, HI, IL, IN, MD, MI, MN, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI.",
      "state": "MD",
      "product_description": "The BD MAX MRSA Assay, catalogue #442953.    An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.",
      "report_date": "20140917",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Becton Dickinson & Co.",
      "recall_number": "Z-2618-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "68991",
      "termination_date": "20160509",
      "recall_initiation_date": "20140723",
      "postal_code": "21152-0999",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}