{
  "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": "2026-09-20",
    "results": {
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      "limit": 1,
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  "results": [
    {
      "cfres_id": "214583",
      "product_res_number": "Z-2515-2025",
      "event_date_initiated": "2025-05-30",
      "event_date_posted": "2025-09-04",
      "recall_status": "Open, Classified",
      "res_event_number": "97106",
      "product_code": "LGD",
      "k_numbers": [
        "K090847"
      ],
      "product_description": "Platelia Toxo IgM Catalog Number 26211\nUDI Code: 03610520005552\n\nThe Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.",
      "code_info": "Catalog Number: 26211\nUDI-DI code: 03610520005552\nBatch/Lot Number: 4L0054",
      "firm_fei_number": "3002701146",
      "recalling_firm": "Bio-Rad Laboratories, Inc.",
      "address_1": "14620 Ne North Woodinville Way",
      "city": "Woodinville",
      "state": "WA",
      "postal_code": "98072-8440",
      "additional_info_contact": "Anna Gralinska-Schram\n510-741-6643",
      "reason_for_recall": "Due to a risk of false positive results that could lead to unnecessary medical treatment.",
      "root_cause_description": "Process control",
      "action": "On 05/30/2025, the firm sent via email an \"URGENT MEDICAL DEVICE NOTIFICATION\" to customers informing them that, as a result of an internal investigation, it was revealed that samples taken from a frozen negative control panel tested unexpectedly interpreted as equivocal or positive results.\n\nCustomer are instructed to:\n. As the issue can alter product performance of the affected lots by reducing specificity and\nincreasing the number of equivocal results, interpret positive results with caution and\ncontact Bio-Rad Technical Support if you observe an unusual rate of false positive results.\n. Refer to the test limitations, as outlined in Section 9 Limitations of the\nProcedure, of the IFU 0002043 version 2023/11:  Diagnosis of recent infection by T. gondii can only be established on the basis of a combination of clinical and serological data. The result of a single serum sample does not constitute sufficient proof for diagnosis of recent infection .\n. As noted in Section 8 Interpretation of Results, positive IgM results should be followed\nby confirmatory steps in accordance with CDC guidelines before initiating or continuing\ntreatment.\n\nFor questions or assistance, contact Bio-Rad Technical Support at 1-800-224-6723 or by email at TechSupportUSSD-Redmond@Bio-Rad.com",
      "product_quantity": "35 kits",
      "distribution_pattern": "U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.",
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        "device_name": "Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii",
        "medical_specialty_description": "Microbiology",
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