{
  "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": "209901",
      "product_res_number": "Z-0118-2025",
      "event_date_initiated": "2024-07-31",
      "event_date_posted": "2024-10-17",
      "recall_status": "Open, Classified",
      "res_event_number": "95285",
      "product_code": "DEW",
      "k_numbers": [
        "K963868"
      ],
      "product_description": "IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610\n\nIGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.",
      "code_info": "Catalog Number: 447610\nUDI-DI code: 15099590221195\nLot Numbers:\nM307362\nM309410",
      "firm_fei_number": "2050012",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "city": "Brea",
      "state": "CA",
      "postal_code": "92821-6232",
      "additional_info_contact": "Courtney Walton\n714-961-5321",
      "reason_for_recall": "Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU",
      "root_cause_description": "Employee error",
      "action": "During the week of 08/15/2024, the firm an \"URGENT MEDICAL DEVICE RECALL\" Letter via first class mail and/or email.  The letter informed customer that Beckman Coulter discovered that IMMAGE Immunochemistry Systems IGM Immunoglobulin M reagent lots are not meeting the sensitivity statement in the IFU:  Sensitivity is defined as the lowest measurable concentration which can be distinguished from zero with 95% confidence. Sensitivity for IGM determination is 4.2 mg/dL. .\n\nCustomers are instructed to:\n-Discontinue use of affected IMMAGE Immunochemistry Systems IGM Immunoglobulin M reagent lots and to follow product replacement instructions.\n-Review the Safety Data Sheet (SDS) and discard according to their laboratory's Standard Operating Procedures and/or their local regulations. SDS is available on www.beckmancoulter.com\n-Share the content of Recall Letter with their lab and/or medical director regarding the need to perform  a retrospective review of patient results.\n\nBeckman Coulter is no longer distributing the affected lots.\n\nFor questions, contact Customer Support Center:\n. From website: http://www.beckmancoulter.com\n. By phone: call 1-800-854-3633 in the United States.\no Outside the United States, contact local Beckman Coulter representative.\n. For customers in the United States, if need replacement product:\no Complete the attached  Replacement Order Form  and email to askbeckman@beckman.com or fax to (866) 294-7850 OR\no Call Client Services at (800) 526-3821\n. For customers in other geographies, contact local Beckman Coulter Representative for replacement.",
      "product_quantity": "12,102 reagents",
      "distribution_pattern": "U.S.:  AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA,  and TX\n\nO.U.S.: Australia, Belgium, Brazil, Chile, China, Czechia, Ecuador, France, Germany, Greece, Hong Kong, India, Italy, Kuwait, Mexico, Philippines, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Taiwan Province of China, and Turkey,",
      "openfda": {
        "k_number": [
          "K882083",
          "K812453",
          "K933314",
          "K791281",
          "K790702",
          "K812630",
          "K875254",
          "K893419",
          "K821018",
          "K812664",
          "K790704",
          "K810056",
          "K882369",
          "K770669",
          "K871352",
          "K943997",
          "K993281",
          "K890416",
          "K842329",
          "K770961",
          "K791824",
          "K963974",
          "K962202",
          "K832264",
          "K921575",
          "K801281",
          "K911610",
          "K924197",
          "K983221",
          "K833402",
          "K812495",
          "K770484",
          "K810694",
          "K871340",
          "K800897",
          "K812489",
          "K853465",
          "K891385",
          "K832258",
          "K772252",
          "K830594",
          "K831101",
          "K791403",
          "K850583",
          "K951635",
          "K811126",
          "K772077",
          "K040434",
          "K760145",
          "K841816",
          "K770597",
          "K050113",
          "K993928",
          "K851541",
          "K802257",
          "K761224",
          "K800398",
          "K873870",
          "K800451",
          "K934324",
          "K010617",
          "K852589",
          "K862764",
          "K800119",
          "K872800",
          "K812328",
          "K861059",
          "K880784",
          "K875356",
          "K770668",
          "K963868",
          "K965108",
          "K812484",
          "K900943",
          "K955798",
          "K791285"
        ],
        "registration_number": [
          "3003601075",
          "2050012",
          "9610099",
          "2084025",
          "9615754",
          "9610806",
          "3002809144",
          "3006198300",
          "3013059683",
          "3003423869",
          "2242436",
          "1000403749",
          "9610126",
          "1181121",
          "3016438761",
          "3009189893",
          "3019906",
          "3005094123",
          "3000148879",
          "3005333358",
          "2050010",
          "3004493545",
          "9610529",
          "9615037",
          "3003795116"
        ],
        "fei_number": [
          "3003601075",
          "3002806559",
          "2050012",
          "2084025",
          "3002809144",
          "3006198300",
          "3013059683",
          "3003423869",
          "2242436",
          "1000403749",
          "3008237827",
          "3002806560",
          "1181121",
          "3016438761",
          "3002806778",
          "3003261083",
          "3009189893",
          "3019906",
          "3005094123",
          "3000148879",
          "3001644026",
          "3005333358",
          "2050010",
          "3004493545",
          "3003795116"
        ],
        "device_name": "Igg, Antigen, Antiserum, Control",
        "medical_specialty_description": "Immunology",
        "regulation_number": "866.5510",
        "device_class": "2"
      }
    }
  ]
}