{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "161514",
      "product_res_number": "Z-0825-2018",
      "event_date_initiated": "2018-02-13",
      "event_date_created": "2018-03-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-10-29",
      "res_event_number": "79176",
      "product_code": "JLS",
      "product_description": "ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239",
      "code_info": "All lots",
      "firm_fei_number": "3005529799",
      "recalling_firm": "Tosoh Bioscience Inc",
      "address_1": "3600 Gantz Rd",
      "city": "Grove City",
      "state": "OH",
      "postal_code": "43123-1895",
      "additional_info_contact": "Danielle Konfal\n614-277-4748",
      "reason_for_recall": "Falsely elevated progesterone assay values will occur when using certain progesterone assay part numbers due to cross reactivity of DHEA-S, a metabolite of the DHEA (dehydroepiandrosterone) supplement.",
      "root_cause_description": "Device Design",
      "action": "The assays identified in the above table must not be used to report results for patients who are taking DHEA supplements.\n\" For patients that are taking DHEA supplements, an alternative testing method which is not expected to show cross reactivity to DHEA-S should be used such as Liquid Chromatography-Mass Spectroscopy (LCMS).\n\" Please review the information in this Urgent Medical Device Recall with your Medical Director and/or Lab Director, as soon as possible.\n\" Continue to use the Progesterone Assays for patients who are not receiving DHEA supplements or therapy.\n\" Complete and return the attached Urgent Medical Device Recall Acknowledgement Form within 15-days.\n\" Maintain this notification with your laboratory records and forward this information to others who may have received this product.\n\" If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the products identified in the table above, contact Tosoh Technical Support 24 hours a day, seven days a week at 1(800) 248-6764 or email Bernadette.OConnell@tosoh.com.\n\" Should you have any questions regarding this medical device recall, please feel free to contact Bernadette OConnell at 1(800) 248-6764, or by email at Bernadette.OConnell@tosoh.com. We will be available to answer any questions Monday - Friday, from 8:00 AM to 5:00 PM (PST).",
      "product_quantity": "5579",
      "distribution_pattern": "Distributed in 39 states: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI.",
      "openfda": {
        "k_number": [
          "K871211",
          "K971725",
          "K811907",
          "K894049",
          "K790440",
          "K884100",
          "K873431",
          "K800922",
          "K820534",
          "K850056",
          "K770732",
          "K910683",
          "K811369",
          "K791051",
          "K864855",
          "K964841",
          "K933269",
          "K944211",
          "K955025",
          "K933635",
          "K800126",
          "K955769",
          "K950570",
          "K810804",
          "K813484",
          "K854094",
          "K931228",
          "K973898",
          "K830880",
          "K933128",
          "K884794",
          "K911512",
          "K972133",
          "K790911",
          "K845026",
          "K854675",
          "K782009",
          "K040923",
          "K880934",
          "K840886",
          "K854649",
          "K890428",
          "K935138",
          "K864156",
          "K890836",
          "K860924",
          "K932955",
          "K832297",
          "K952075",
          "K920230",
          "K832694",
          "K923410",
          "K914462",
          "K820686",
          "K841333",
          "K951630",
          "K965084"
        ],
        "registration_number": [
          "8010132",
          "2432235",
          "9612316",
          "8031673",
          "2182595",
          "2419955",
          "3017894300",
          "3022178699",
          "2245285",
          "3005542422",
          "2020726",
          "3003760091",
          "3017019647",
          "3005529799",
          "3009984016",
          "3003559191",
          "1827821",
          "3002809144",
          "2133982",
          "3007111389",
          "3006198300",
          "1219913",
          "3011989923",
          "2029372",
          "1036362",
          "9610126",
          "2122870",
          "8021924",
          "2250051",
          "3009335633",
          "3002806944",
          "3009491259",
          "3007118747",
          "3004192065",
          "2517506",
          "9710337",
          "8020790",
          "1222302",
          "8020888",
          "2032682",
          "3017379203",
          "3005094123",
          "1319681",
          "3005333358",
          "3002800697",
          "2032839",
          "3033967997"
        ],
        "fei_number": [
          "3002808328",
          "3002676602",
          "2432235",
          "3017894300",
          "2419955",
          "2182595",
          "3002806559",
          "3022178699",
          "2245285",
          "3003760091",
          "3005542422",
          "2020726",
          "3017019647",
          "3005529799",
          "3009984016",
          "3003559191",
          "1827821",
          "3002809144",
          "1000306617",
          "3007111389",
          "3006198300",
          "1219913",
          "3011989923",
          "1036362",
          "3000717645",
          "3002485711",
          "3004185580",
          "1000121039",
          "2122870",
          "2250051",
          "3009335633",
          "3002806944",
          "3003952975",
          "1000611339",
          "3009491259",
          "1000136573",
          "3007118747",
          "3004192065",
          "2517506",
          "3002806808",
          "3017379203",
          "3005094123",
          "2967",
          "3005333358",
          "3002800697",
          "3007019572",
          "3033967997"
        ],
        "device_name": "Radioimmunoassay, Progesterone",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1620",
        "device_class": "1"
      }
    }
  ]
}