{
  "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": "2026-04-29",
    "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 TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50.",
      "address_2": "",
      "product_quantity": "335 CE-IVD TDFs; 48 JPN-IVD TDFs",
      "code_info": "Material Number: CE-IVD: 04803531190 Kit, 05574455190 TDF; JPN-IVD: 04653360190 Kit, 05574447190 TDF. Lot/Serial Number: CE-IVD: All Kits, JPN-IVD: All Kits.",
      "center_classification_date": "20130131",
      "distribution_pattern": "Worldwide Distribution - Foreign (22 EU countries - Austria, Belgium, Bulgaria, Croatia, Cypress, Czech Republic, Denmark, Germany, Finland, France, Greenland, Hungary, Iceland, Italy, Luxembourg, Netherland, Norway, Sweden, Switzerland, Spain, Turkey, UK); (41 Rest of World countries - See Attachment for full country distribution + Japan, Portugal and Mexico)",
      "state": "NJ",
      "product_description": "COBAS TaqMan Mycobacteria tuberculosis (MTB)  Test FOR IN VITRO DIAGNOSTIC USE.",
      "report_date": "20130206",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Roche Molecular Systems, Inc.",
      "recall_number": "Z-0762-2013",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "63997",
      "termination_date": "20150806",
      "more_code_info": "",
      "recall_initiation_date": "20121128",
      "postal_code": "08876-3733",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}