{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "177264",
      "product_res_number": "Z-0739-2020",
      "event_date_initiated": "2019-10-14",
      "event_date_created": "2019-12-26",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-11-13",
      "res_event_number": "84123",
      "product_code": "DCF",
      "product_description": "7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.",
      "code_info": "Lot with Expiry Date: D6289\t2019-11-20 E6382\t2020-01-15 F6602\t2020-05-02 G6679\t2020-08-13 H6897\t2020-10-01 J7129\t2021-01-23 K7421\t2021-07-01 L7592\t2021-08-26",
      "firm_fei_number": "2250051",
      "recalling_firm": "Ortho Clinical Diagnostics Inc",
      "address_1": "1001 US Highway 202",
      "city": "Raritan",
      "state": "NJ",
      "postal_code": "08869-1424",
      "additional_info_contact": "Joe Falvo\n585-453-3452",
      "reason_for_recall": "Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days",
      "root_cause_description": "Device Design",
      "action": "On August 9, 2019 the firm distributed Urgent Medical Device Recall Communication letters by via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only) summarizing the reason as Ortho Clinical Diagnostics determined that VITROS 7% BSA and VITROS Urine Electrolyte Diluent (UED) do not meet the current OAS time of d 7 days when stored on the VITROS 250/350 System in a 2mL cup only. Orthos internal testing compared results from samples diluted with diluent stored on the analyzer versus fresh diluent. When using 7% BSA or UED stored in a 2mL cup for 7 days, the differences in the results vs fresh diluent were >10% for some assays. It explained as a resolution:\n\" The OAS of 7% BSA and UED in 2mL cups has been revised to d24 hours.\n\" Current OAS time remains at d7 days for storage in 5mL and 10 mL bottles.\n\" The Instructions for Use and appropriate User Documentation will be revised at a future date.\nIt instructs them to:\n- Send the enclosed customer letter to all customers to whom you shipped or know to have a VITROS 250/350 System. Please continue to provide this letter to new customers until the Instructions for Use are updated.\n- Complete and return the Confirmation of Receipt form by October 22, 2019.",
      "product_quantity": "16,584",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution and countries BM, AU, BR, CA, CL, CN, CO, IN, JP, MX, SG, GB, FR, DE, IT, ES, PT,  PL, RU, DK, NO, SE, BE, NL.",
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        "registration_number": [
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        ],
        "device_name": "Albumin, Antigen, Antiserum, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5040",
        "device_class": "2"
      }
    }
  ]
}