{
  "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": [
    {
      "status": "Terminated",
      "city": "Brea",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73417",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "address_2": "N/A",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Affected geographies: Bahamas, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, French Guiana, Germany, Ghana, Greece, Guadeloupe, Guatemala, India, Israel, Italy, Japan, Kazakhstan, Lithuania, Mexico, Morocco, Netherlands, Northern Mariana Islands, Panama, Paraguay, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, Spain, Taiwan, Tunisia, Turkey, United States, Uruguay, Virgin Islands, Zimbabwe.",
      "recall_number": "Z-1269-2016",
      "product_description": "MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41    Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026.    Japan:  10638819 LabPro v4.11 Software Update Kit  10638820 LabPro v4.11 System Software  10805072 LabPro MBT Non-Connect Systems v4.30  10805073 LabPro MBT Connect Systems v4.30  Canada:  6000-0008 LabPro v4.41 Panel Update-06 Kit  6000-0026 LabPro Connect v4.41 Panel Update-06 Kit  10638823 LabPro v4.11 Software Update Kit  10638825 LabPro v4.11 System Software  10638824 LabPro v4.11 Software Update Kit  Europe:  10638824 LabPro v4.11 Software Update Kit  10638826 LabPro v4.11 System Software  USA:  10714149, LabPro v4.11 Software Update Kit  10714150 LabPro v4.11 System Software  10975000 ASM LabPro-MBT v4.40  10975001 ASM LabPro-MBT v4.40 for Connect  6000-0008 LabPro v4.41 Panel Update-06 Kit  6000-0026 LabPro Connect v4.41 Panel Update-06 Kit  ROW:  6000-0008 LabPro v4.41 Panel Update-06 Kit  10638823 LabPro v4.11 Software Update Kit  10638825 LabPro v4.11 System Software  10638824 LabPro v4.11 Software Update Kit  10638826 LabPro v4.11 System Software    Product Usage:  LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. LabPro AlertEx is a functional subset of the LabPro Data Management System that analyzes MicroScan ID and AST data, or other predefined parameters, against a series of established rules/alerts and notifies the user of unusual and/or critical conditions, which may warrant further analysis or actions.",
      "product_quantity": "2,702 units total (1,032 units in US)",
      "reason_for_recall": "Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.",
      "recall_initiation_date": "20160211",
      "center_classification_date": "20160328",
      "termination_date": "20180104",
      "report_date": "20160406",
      "code_info": "not applicable"
    }
  ]
}