{
  "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": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "cfres_id": "215024",
      "product_res_number": "Z-2545-2025",
      "event_date_initiated": "2025-06-17",
      "event_date_posted": "2025-09-10",
      "recall_status": "Open, Classified",
      "res_event_number": "97271",
      "product_code": "GTY",
      "k_numbers": [
        "K011097"
      ],
      "product_description": "QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC",
      "code_info": "REF/UDI-DI/Lot(Expiration):\n20108/30014613201083/709673(05-FEB-2026), 709676(05-FEB-2026), 709484(09-JAN-2026), 709501(09-JAN-2026), 709520(16-JAN-2026), 709535(16-JAN-2026);\t\n\n20125/30014613201250/709487(09-JAN-2026), 709503(16-JAN-2026), 709509(16-JAN-2026), 709684(12-FEB-2026);\n\n20108SC/0130014613330073/709485(09-JAN-2026), 709502(16-JAN-2026)",
      "firm_fei_number": "2024674",
      "recalling_firm": "Quidel Corporation",
      "address_1": "10165 McKellar Ct",
      "city": "San Diego",
      "state": "CA",
      "postal_code": "92121-4201",
      "additional_info_contact": "954-623-9546 Ext. 7922",
      "reason_for_recall": "Dipstick strep A test has potential for false positive results.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On 6/17/2025, correction notices were mailed to customers who were asked to do the following:\n\n1) Send the enclosed customer letter and Confirmation of Receipt form to customers who were shipped any of the affected lots of Strep A Test from your facility.\n2) The response form asks customers to acknowledge they have discontinued distributing and discarded the affected lots of Strep A Test \n3) Complete and return the Confirmation of Receipt form via email to RA-OCDUS-CONFIRMAD@QUIDELORTHO.COM\n\nIf you have further questions, please contact the firm's Global Services Organization at 1-800-874-1517 or technicalsupport@quidelortho.com.",
      "product_quantity": "22470",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of MA, NJ, MD, NC, SC, FL, TN, MS, MN, IL, MO, KS, LA, TX, CO, ID, CA, AK, NY, PA and the countries of Canada, Italy, Denmark, Norway, Sweden, Finland, Thailand, Israel, Slovenia, Turkey.",
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        "device_name": "Antigens, All Groups, Streptococcus Spp.",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3740",
        "device_class": "1"
      }
    }
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}