{
  "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": "36550",
      "product_res_number": "Z-0435-05",
      "event_date_initiated": "2001-12-14",
      "event_date_posted": "2005-01-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-11-02",
      "res_event_number": "30764",
      "product_code": "LID",
      "k_numbers": [
        "K984108"
      ],
      "product_description": "B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01.  The reagent is manufactured by Abbott Laboratories, Abbott Park, IL.  The ARCHITECT instrument is manufactured by Abbott Laboratories, Irving Texas",
      "code_info": "All lots manufactured.",
      "firm_fei_number": "1628664",
      "recalling_firm": "Abbott Laboratories, Inc",
      "address_1": "1921 Hurd Drive",
      "address_2": "PO Box 152020",
      "city": "Irving",
      "state": "TX",
      "postal_code": "75038",
      "reason_for_recall": "Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on the same analyzer due to carryover.  B-12 results are not impacted.",
      "root_cause_description": "Other",
      "action": "The firm initiated the recall via letter on December 14 and 16, 2004 directing consignees to perform the two tests on different machines or to contact the customer service representative in the event the consignee only has one machine.",
      "product_quantity": "6860 units",
      "distribution_pattern": "The B12 reagent was only distributed to foreign countries including Canada, Germany, Hong Kong, Japan, Dingapore, Australia, and New Zealand",
      "openfda": {}
    }
  ]
}