{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "104837",
      "product_res_number": "Z-0297-2012",
      "event_date_initiated": "2011-06-08",
      "event_date_posted": "2011-11-28",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-02-17",
      "res_event_number": "60233",
      "product_code": "DLJ",
      "k_numbers": [
        "K872644"
      ],
      "product_description": "Multigent Vancomycin Calibrators;\nManufactured by Microgenics Corp, Fremont, CA.\nDistributed by: Abbott Diagnostics, Abbott Park, IL \n\n\nProduct Usage:\nThe Multigent Vancomycin calibrators are intended for use in the calibration of the multiagent vancomycin\nVancomycin is a commonly used antibiotic to treat staphylococcus and other gram-positive bacterial infections.",
      "code_info": "Catalog number: 6E44-01; Lot 59446762, Exp 3/31/12; lot 59391741, Exp 12/31/2011.",
      "firm_fei_number": "3010939897",
      "recalling_firm": "Microgenics Corp",
      "address_1": "46360 Fremont Blvd",
      "city": "Fremont",
      "state": "CA",
      "postal_code": "94538",
      "additional_info_contact": "Lisa Charter\n510-979-5000",
      "reason_for_recall": "Complaint from the sole distributor that the third party control material is recovering high, and outside the published range.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Microgenics sent a Product Removal notification letter dated June 15, 2011 to all affected customers. The letter identified the affected product, the problem, and the necessary actions to be taken.  Customers were instructed to discontinue use and dispose of the affected product per local waste ordinances, review all patient results reported with the use of this lot, and retain a copy of this notification for their records.  The letter states that if the affected product has been forwarded to another laboratory, a copy of the letter is to be provided to them.  An alternative calibrator is available to customers impacted. It can be ordered by calling Thermo Fischer Scientific Customer Service at 1-800-232-3342.\n\nQuestions regarding the information should be forwarded to Abbott Customer Service at 1-877-4ABBOTT.",
      "product_quantity": "809 kits lot 59446762;  651 kits lot 59391741",
      "distribution_pattern": "Nationwide Distribution (USA) in the state of ILLINOIS",
      "openfda": {
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          "K993022",
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        ],
        "registration_number": [
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          "1220972",
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        "device_name": "Calibrators, Drug Specific",
        "medical_specialty_description": "Clinical Toxicology",
        "regulation_number": "862.3200",
        "device_class": "2"
      }
    }
  ]
}