{
  "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": "Branchburg",
      "address_1": "1080 US Highway 202 S",
      "reason_for_recall": "The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection.  A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others.  The United States is not impacted, as the cobas MRSA/SA nucleic acid test for use on the cobas liat system is not available in the US.",
      "address_2": "",
      "product_quantity": "136 kits",
      "code_info": "Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).",
      "center_classification_date": "20180326",
      "distribution_pattern": "Worldwide distribution.  Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland.  US product is not affected.",
      "state": "NJ",
      "product_description": "Nucleic Acid test intended for screening for MRSA/SA.  Each kit has 20 tubes.  in vitro diagnostic.",
      "report_date": "20180404",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Roche Molecular Systems, Inc.",
      "recall_number": "Z-1195-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "79375",
      "termination_date": "20200427",
      "more_code_info": "",
      "recall_initiation_date": "20171027",
      "postal_code": "08876-3733",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}