{
  "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": "189879",
      "product_res_number": "Z-0235-2022",
      "event_date_initiated": "2021-09-17",
      "event_date_created": "2021-11-16",
      "recall_status": "Open, Classified",
      "res_event_number": "88874",
      "product_code": "LIP",
      "k_numbers": [
        "K170413"
      ],
      "product_description": "BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack\n\nThe BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasma",
      "code_info": "Catalog Number: 12000650\nUDI Code: 03610520653012\nLot Number: 301210",
      "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\n510-741-6063",
      "reason_for_recall": "Due to two issues:\n1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and \n2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On 09/17/2021, the Recalling Firm sent an \"URGENT PRODUCT NOTIFICATION\" Letter to customer via overnight FedEx informing them of two issues their Syphilis Total and RPR (Rapid Plasma Reagin) kits:\n1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation between the mass COVID vaccinations and false reactive RPR results, and \n2) During routine stability monitoring, an increase in mean bias above specification was observed which can cause elevated RPR reactivity potentially due to early shelf-life failure.\n\nCustomer are instructed to:\n-Immediately discontinue use and dispose of any unused product of reagent packs and calibrator set according to local waste management procedures.\n-Complete the customer response form and return it to their local Recalling Firm Technical Support, or return this form to Techsupport.ussd@bio-rad.com or the Toll-Free Fax 1-888-228-0688 within 10 days of receiving this notice..\n-If the affected products have been further distributed or transferred, notify those customers of the field action.\n\nFor additional questions, contact local Bio-Rad Technical Support.",
      "product_quantity": "11,610 units",
      "distribution_pattern": "Worldwide Distribution: U.S.(nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI,  and WV; O.U.S.(foreign) countries of: France, Germany, Israel, Italy, Russian Federation, South Africa, Spain, and Taiwan.",
      "openfda": {
        "k_number": [
          "K014233",
          "K241534",
          "K153730",
          "K881425",
          "K091361",
          "K820934",
          "K961317",
          "K850329",
          "K904524",
          "K883938",
          "K160910",
          "K895965",
          "K093837",
          "K061247",
          "K960493",
          "K992552",
          "K241427",
          "K932453",
          "K895964",
          "K102283",
          "K883939",
          "K910487",
          "K120439",
          "K001552",
          "K170413",
          "K871548",
          "K050590",
          "K102400",
          "K063866",
          "K112343",
          "K001525",
          "K211302",
          "K900654",
          "K153145",
          "K053570"
        ],
        "registration_number": [
          "2245285",
          "3011989923",
          "1319681",
          "2431980",
          "3000254998",
          "1641328",
          "2915274",
          "3002809144",
          "2182595",
          "2032364",
          "3005360469",
          "2029372",
          "3002895169",
          "9610126",
          "9610240",
          "3026565854",
          "3009178048",
          "1219913",
          "3005333358",
          "3002806944",
          "2242436",
          "2432235",
          "1318354",
          "8023060",
          "2122870",
          "3022178699",
          "3002800697",
          "3032705"
        ],
        "fei_number": [
          "2245285",
          "3005670738",
          "3011989923",
          "3003992026",
          "2431980",
          "3000254998",
          "1641328",
          "2915274",
          "3002809144",
          "2182595",
          "3002895169",
          "3003323921",
          "3002806559",
          "3026565854",
          "3009178048",
          "1219913",
          "1000306617",
          "1000136573",
          "3005333358",
          "3002806944",
          "2242436",
          "3002701146",
          "3002808212",
          "2432235",
          "1318354",
          "2122870",
          "3022178699",
          "3002800697"
        ],
        "device_name": "Enzyme Linked Immunoabsorption Assay, Treponema Pallidum",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3830",
        "device_class": "2"
      }
    }
  ]
}