{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 3
    }
  },
  "results": [
    {
      "cfres_id": "222301",
      "product_res_number": "Z-0205-2027",
      "event_date_initiated": "2026-08-14",
      "event_date_posted": "2026-10-22",
      "recall_status": "Open, Classified",
      "res_event_number": "99724",
      "product_code": "OHQ",
      "product_description": "Techno-Path  Multichem AE Unassayed Level 1\nREF:AE621X",
      "code_info": "UDI: (01)05391523442800/Lot # 65705261",
      "firm_fei_number": "3008156187",
      "recalling_firm": "TECHNO-PATH MANUFACTURING LTD.",
      "address_1": "Fort Henry Business Park",
      "city": "Ballina Tipperary",
      "country": "Ireland",
      "additional_info_contact": "Bernd Hass\n+353-61525700",
      "reason_for_recall": "A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. \n\nThe impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision points.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On August 14, 2026, Techno Path Manufacturing Ltd has issued a medical device correction to consignees via email. Techno Path Manufacturing Ltd informed consignees to please verify their inventory against the affected product codes and lot numbers.\n\nTechno Path Manufacturing Ltd. has informed the consignees to take the following actions:\n1. Immediately place all affected inventory on hold and prevent further distribution.\n2. Quarantine all affected product currently under your control.\n3. Confirm that there has been no distribution of the impacted lots to customers.\n4. Confirm receipt of this notification and provide inventory and distribution details to Technopath Manufacturing Ltd. within 3 business days.\n5. Arrange return or destruction of affected inventory in accordance with instructions provided by Technopath Manufacturing Ltd.",
      "product_quantity": "832 units",
      "distribution_pattern": "US Nationwide distribution in the state of Massachusetts.",
      "openfda": {
        "registration_number": [
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          "3049139337",
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          "8043909",
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          "1643621",
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        "fei_number": [
          "3002895169",
          "3012918440",
          "1318994",
          "3010939897",
          "3008386529",
          "1000122536",
          "2244821",
          "3021090658",
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          "3027062375",
          "3032324401",
          "3003407015",
          "3013508066",
          "2023365",
          "3002809144",
          "1000136573",
          "3016838963",
          "3005333358",
          "1220394",
          "3002807876",
          "3012963943",
          "3004530258",
          "3003356736",
          "2026994",
          "1524213",
          "3004737529",
          "3004175381",
          "3003855297",
          "3009383609",
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          "3004973408",
          "3000202849",
          "1000611339",
          "1050155",
          "3014607865",
          "3003610890",
          "3003825930",
          "3000308930",
          "2432495",
          "1627497",
          "3008156187",
          "3049139337",
          "3009672007",
          "3002808498",
          "3003741796",
          "3004493545",
          "3002642396",
          "3010934853",
          "1000135102",
          "3005695774",
          "3013887826",
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          "1643621",
          "3050015",
          "2150138",
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          "2250051",
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        ],
        "device_name": "Multi-Analyte Controls Unassayed",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1660",
        "device_class": "1"
      }
    }
  ]
}