{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "cfres_id": "30124",
      "product_res_number": "Z-0316-04",
      "event_date_initiated": "2003-10-28",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-08-13",
      "res_event_number": "27577",
      "product_code": "LSR",
      "k_numbers": [
        "K943812"
      ],
      "product_description": "VIDAS Lyme IgG and IgM LYT, Ref  #30 298, containing 60 LYT STR (reagent strip labels), 2 x 30 LYT SPR (Solid Phase Receptable) pouches, 1 x 1.5 ml LYT C1 (human) (positive control bottle), 1 x 1.5 ml LYT C2 (human) (negative control bottle), and 1 x 1.5 ml LYT S1 (human) (standard bottle).   The responsible firm on the kit label is bioMerieux sa, 69280 Marcy l''Etoile France.  The responsible firm on the insert is bioMerieux, Inc., Durham, NC.",
      "code_info": "Lot #777450001",
      "firm_fei_number": "1039284",
      "recalling_firm": "Biomerieux, Inc.",
      "address_1": "100 Rodolphe St",
      "city": "Durham",
      "state": "NC",
      "postal_code": "27712-9402",
      "additional_info_contact": "Anita M. McClernon, MS, RAC\n919-620-2288",
      "reason_for_recall": "Kit may contain incorrect components",
      "root_cause_description": "Other",
      "action": "Recall letters dated 10/28/03 were issued via regular mail instructing the customer to examine the kits to determine whether they contain the CMV IgG SPRS and destroy them if found.",
      "product_quantity": "329 kits",
      "distribution_pattern": "Distribution was made nationwide to hospitals and laboratories.",
      "openfda": {
        "k_number": [
          "K911330",
          "K971169",
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          "K911145",
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        ],
        "device_name": "Reagent, Borrelia Serological Reagent",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3830",
        "device_class": "2"
      }
    }
  ]
}