{
  "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,
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  },
  "results": [
    {
      "cfres_id": "48782",
      "product_res_number": "Z-0245-2007",
      "event_date_initiated": "2006-10-09",
      "event_date_posted": "2006-12-05",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-05-22",
      "res_event_number": "36512",
      "product_code": "CHI",
      "k_numbers": [
        "K845027"
      ],
      "product_description": "VITROS Chemistry Products LIPA Slides GEN 48,  Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and  REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS Chemistry Systems typically used in hospital laboratories. Ortho-Clinical Diagnostics, a Johnson & Johnson company. Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626. 510(k) #: K845027 (18 January 1985).  Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08",
      "code_info": "Catalog/REF Nos. 166 8409 and 829 7749.  All lots.",
      "firm_fei_number": "1000136573",
      "recalling_firm": "Ortho-Clinical Diagnostics",
      "address_1": "100 Indigo Creek Drive",
      "city": "Rochester",
      "state": "NY",
      "postal_code": "14626",
      "additional_info_contact": "Mr. Joseph Falvo\n585-453-5735",
      "reason_for_recall": "The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS LIPA slides if they have been stored on the VITROS Chemistry Systems for more than 2 days.",
      "root_cause_description": "Other",
      "action": "On 10/09/06, Ortho-Clinical Diagnostics sent \"IMPORTANT DISTRIBUTOR NOTIFICATION\" Letters and \"Confirmation of Receipt\" Forms via Federal Express to all distributor accounts informing them of the \"field correction\", and instructing them  to inform their customers who received these slides of this issue. \nOCD foreign affiliates were informed of this action by e-mail on 10/09/06, and instructed them to inform their customers who received the LIPA slides of this \"field correction\". OCD also sent  \"IMPORTANT PRODUCT CORRECTION NOTIFICATION\" Letters and \"Confirmation of Receipt\" Forms to US end-user consignees that received the LIPA slides directly from OCD via US Postal Service, informing them of this \"field correction\" and  that they may continue to use their current lot of Coating 3235 LIPA Slides until replacement product arrived providing that they followed the instructions in the letter.",
      "product_quantity": "Cat./REF # 166 8409: Domestic - 3031, Foreign - 2511; Cat./ REF # 829 7749: Domestic - 1682, Foreign - 3553",
      "distribution_pattern": "Worldwide distribution",
      "openfda": {
        "k_number": [
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        "registration_number": [
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        "fei_number": [
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          "1000122044"
        ],
        "device_name": "Lipase-Esterase, Enzymatic, Photometric, Lipase",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1465",
        "device_class": "1"
      }
    }
  ]
}