{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "181440",
      "product_res_number": "Z-2982-2020",
      "event_date_initiated": "2020-04-21",
      "event_date_created": "2020-09-18",
      "recall_status": "Open, Classified",
      "res_event_number": "85636",
      "product_code": "LIP",
      "k_numbers": [
        "K170413"
      ],
      "product_description": "BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.",
      "code_info": "The RPR assay will be disabled beginning with reagent lot 301142 and future manufactured lots of the BioPlex 2200 Syphilis Total & RPR assay (Catalog No. 12000650, UDI 03610520653012) and calibrator lot 52216 (Catalog No. 12000651, UDI 03610520652770).  Product Code 1: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM (LIP), Product Code 2: ANTIGENS, NONTREPONEMAL, ALL (GMQ), Product    Code 3: CALIBRATOR, SECONDARY (JIT), Product Code 4:SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX).",
      "firm_fei_number": "3008272466",
      "recalling_firm": "Bio-Rad Laboratories, Inc.",
      "address_1": "6565 185th Ave Ne",
      "city": "Redmond",
      "state": "WA",
      "postal_code": "98052-5039",
      "additional_info_contact": "Tina Cuccia\n425-881-8300",
      "reason_for_recall": "The increased level of RPR reactivity in the BioPlex 2200 Syphilis Total & RPR kit material number 12000650.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "Consignees that have purchased active lots of the BioPlex 2200 Syphilis Total and RPR kit have been notified of the  Field Correction via a customer letter sent via Fed Ex overnight ; date issued 04/21/2020.  The communication was to inform that  the RPR portion of the BioPlex 2200 Syphilis Total & RPR assay will be temporarily disabled.  The RPR assay will be disabled beginning with reagent lot 301142 of the BioPlex 2200 Syphilis Total & RPR assay (Catalog No. 12000650, UDI 03610520653012) and calibrator lot 52216 (Catalog No. 12000651, UDI 03610520652770). The reporting of the RPR assay results will be disabled by the installation of a new assay protocol file (APF).  The communication includes that there are no modifications to the chemistry of the assay reagents or processing of the assay by the BioPlex 2200 System. The RPR assay will remain disabled until further notice. Consignees are asked to complete and return the Customer Response form (fax: 1-888-228-0688/email: Techsupport.ussd@bio-rad.com) to confirm receipt of the communication and to receive instructions for installation of the new APF; return the form within 10 days of receiving the notice. Additionally, consignees are asked to contact their local technical support if there are any questions about the notification.",
      "product_quantity": "12000 kits",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TX, UT, VA, WA, WI, and WV. The countries of Canada (CA), Switzerland (CH), France (FR), Italy (IT), Spain (ES), and Romania (RO), and United Kingdom (GB).",
      "openfda": {
        "k_number": [
          "K241427",
          "K102400",
          "K153145",
          "K102283",
          "K910487",
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          "K960493",
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          "K120439",
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          "K053570",
          "K241534",
          "K061247",
          "K091361",
          "K883939",
          "K160910",
          "K170413",
          "K881425",
          "K895965",
          "K904524",
          "K900654",
          "K871548",
          "K063866",
          "K050590",
          "K850329",
          "K093837",
          "K211302",
          "K895964",
          "K014233",
          "K961317",
          "K153730",
          "K883938",
          "K820934"
        ],
        "registration_number": [
          "1318354",
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          "3002800697",
          "1319681",
          "3002809144",
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          "3011989923",
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        ],
        "fei_number": [
          "1318354",
          "3002895169",
          "3002806559",
          "1219913",
          "3002800697",
          "3002809144",
          "3005670738",
          "3000254998",
          "2182595",
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          "2432235",
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          "3022178699",
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          "2122870",
          "3002806944",
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          "2915274",
          "2245285",
          "3003323921",
          "3005333358",
          "3026565854",
          "1000136573",
          "3003992026",
          "3002701146"
        ],
        "device_name": "Enzyme Linked Immunoabsorption Assay, Treponema Pallidum",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3830",
        "device_class": "2"
      }
    }
  ]
}