{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192368",
      "product_res_number": "Z-0884-2022",
      "event_date_initiated": "2022-03-04",
      "event_date_posted": "2022-04-06",
      "recall_status": "Open, Classified",
      "res_event_number": "89757",
      "product_code": "MKT",
      "pma_numbers": [
        "P200013"
      ],
      "product_description": "Alinity m HBV AMP Kit (US and CE)",
      "code_info": "List Numbers: \n1) 08N47-095 (US); Lots: 519756, 523799, and 524361, Updated to add:  381583, 529391, 529687, 530273, 531598; \n2) 08N47-090 (CE); Lots: 519755, 520957, 522137, 523798, and 524059, Updated to add: \n 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596",
      "firm_fei_number": "3005248192",
      "recalling_firm": "Abbott Molecular, Inc.",
      "address_1": "1300 E Touhy Ave",
      "city": "Des Plaines",
      "state": "IL",
      "postal_code": "60018-3315",
      "additional_info_contact": "Ray Bastian\n224-361-7619",
      "reason_for_recall": "There is a potential for misquantitation high results for negative samples.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On March 4, 2022, Abbott Molecular issued an Urgent Field Safety Notice / Field Correction Recall Notice, Urgent Field Safety Notice, and Dear Health Care Provider letter to all customers who received the Alinity m HBV Amp Kits (List Number 08N47-095 Lot Numbers 519756, 523799, 524361 and List Number 08N47-090 Lot Numbers 519755\n520957, 522137, 523798, and 524059). Consignees are asked to follow the necessary actions outlined in the letter and complete and return the Customer Reply Form.\n\nThe results from the Alinity m HBV assay must be interpreted within the context of all relevant clinical and laboratory findings. If results are inconsistent with patient history and other diagnostics through patient monitoring, a retest of the same sample should be considered.\n\n100% of customers are requested to return to Abbott a Customer Reply Form acknowledging receipt and understanding, and/or a request for assistance.\n\nAbbott personnel will follow up with customers by e-mailing and or follow-up visits/phone calls.\n\nThe firm issued a second Urgent Field Safety Notice / Field Correction Recall notice on 01/13/2023 to consignees that received the newly identified lot numbers: (List Number 08N47-095 Lot Numbers 381583, 529391, 529687, 530273, 531598 and List Number 08N47-090 Lot Numbers 380963, 380979, 381021, 529378, 529686, 530272, 531189, 531596).",
      "product_quantity": "4966 kits, updated 101/17/2023",
      "distribution_pattern": "US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA\n\nOUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam",
      "openfda": {
        "pma_number": [
          "P050028",
          "P200013",
          "P170025",
          "P080026",
          "P150014"
        ],
        "device_name": "Hepatitis Viral B Dna Detection",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3174",
        "device_class": "2",
        "registration_number": [
          "3012322232",
          "3004141078",
          "3025663244",
          "9610126",
          "3005248192",
          "2024800",
          "2243471",
          "3003795116",
          "3019837962"
        ],
        "fei_number": [
          "3012322232",
          "3004141078",
          "3002806559",
          "3025663244",
          "3005248192",
          "2024800",
          "2243471",
          "3003795116",
          "3019837962"
        ]
      }
    }
  ]
}