{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Boston",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90358",
      "recalling_firm": "Haemonetics Corporation",
      "address_1": "125 Summer St",
      "address_2": "",
      "postal_code": "02110-1616",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "Z-1298-2022",
      "product_description": "Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay -  PlateletMapping ADP & AA (07-014),  PlateletMapping ADP (07-015),  PlateletMapping AA (07-016).    Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG Manager Software (versions 1.1-4.3.1)",
      "product_quantity": "111",
      "reason_for_recall": "When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.",
      "recall_initiation_date": "20220419",
      "center_classification_date": "20220628",
      "termination_date": "20240327",
      "report_date": "20220706",
      "code_info": "This correction is applicable when TEG 5000 PlateletMapping (Item # 07-014, 07-015, 07-016) is performed on a TEG 5000 analyzer (Item # 07-022, 07-033) that is connected to TEG Manager Software which includes viewing of TEG 5000 results.  Code Info: UDI-DI: (01)30812747018184  Software Version: TEGM 1.1 and later, TAS v4.2.3",
      "more_code_info": ""
    }
  ]
}