{
  "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": "35734",
      "product_res_number": "Z-0262-5",
      "event_date_initiated": "2004-10-25",
      "event_date_posted": "2004-11-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-06-17",
      "res_event_number": "30362",
      "product_code": "CHI",
      "k_numbers": [
        "K970905"
      ],
      "product_description": "SYNCHRON Clinical Systems Lipase (LIPA) Reagent; Classification name: 862.1465",
      "code_info": "Part number: 465101  Lot Numbers - Date of Mfg - Expiration Date M310237 - 10/29/2003 - 10/31/2004 M401010 - 01/15/2004 - 01/31/2005  M403026 - 03/05/2004 - 03/31/2005 M406041 - 06/10/2004 - 06/30/2005",
      "firm_fei_number": "2050012",
      "recalling_firm": "Beckman Coulter Inc",
      "address_1": "200 S Kraemer Blvd",
      "city": "Brea",
      "state": "CA",
      "postal_code": "92822-6208",
      "additional_info_contact": "Kathleen M. Jaker\n714-966-3666",
      "reason_for_recall": "Beckman Coulter has confirmed that occasionally a cuvette may be skipped during the SYNCHRON Lipase Wash (LIWA) procedure. If this occurs, there is the potential for carryover into the SYNCHRON Lipase (LIPA) assay, resulting ina substantial positive bias affecting Lipase (LIPA) results.",
      "root_cause_description": "Other",
      "action": "The week of 10/25/2004, a product corrective action (PCA) letter was mailed vis U.S. mail to all customers shipped LIPA reagent for the 24 months preceding the discovery of the issue. Customers instructed to repeat any sample that produces a lipase value of > 170 U/L that cannot be confirmed by patient history.",
      "product_quantity": "6,698",
      "distribution_pattern": "US and Canada",
      "openfda": {
        "k_number": [
          "K900827",
          "K845027",
          "K760786",
          "K921249",
          "K920337",
          "K941085",
          "K811553",
          "K884596",
          "K923917",
          "K952816",
          "K961179",
          "K802842",
          "K952647",
          "K875173",
          "K874640",
          "K970905",
          "K952180",
          "K897150",
          "K874027",
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        ],
        "registration_number": [
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        ],
        "fei_number": [
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        ],
        "device_name": "Lipase-Esterase, Enzymatic, Photometric, Lipase",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1465",
        "device_class": "1"
      }
    }
  ]
}