{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Brea",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88559",
      "recalling_firm": "Beckman Coulter Inc.",
      "address_1": "250 S Kraemer Blvd",
      "address_2": "",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S.: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, ME, MD, MI, MN, MS, MO, NC, ND, NE, NV, NJ, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY     O.U.S.:  Algeria, Andorra, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia and Herzegovina, Brazil, Brunei, Bulgaria, Canada, China, Croatia, Cura¿ao, Czech Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Niger, Nigeria, Norway, Oman, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Swaziland, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vietnam, Yemen, and Zimbabwe",
      "recall_number": "Z-0032-2022",
      "product_description": "Access hsTnI High Sensitivity Troponin I, REF B52699    Access Immunoassay System REAGENT PACK",
      "product_quantity": "293,640 kits",
      "reason_for_recall": "Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack.  The carryover is caused by sample-to-pack carryover predominantly into the particle well of the reagent pack by way of the probe. The particle well then becomes contaminated by the high sample from the probe. The extent of the carryover is dependent on sample concentration and frequency of high concentration samples.",
      "recall_initiation_date": "20210809",
      "center_classification_date": "20211005",
      "report_date": "20211013",
      "code_info": "Catalog Number:B52699  Lot Number / UDI Code:  921491 / (01)15099590693183(17)201130(11)191201(10)921491;  921638 / (01)15099590693183(17)201231(11)200101(10)921638;  921631 / (01)15099590693183(17)210131(11)200201(10)921631;  921750 / (01)15099590693183(17)210131(11)200201(10)921750;  921805 / (01)15099590693183(17)210228(11)200229(10)921805;  921831 / (01)15099590693183(17)210331(11)200331(10)921831;  921943 / (01)15099590693183(17)210430(11)200430(10)921943;  922000 / (01)15099590693183(17)210531(11)200531(10)922000;  922039 / (01)15099590693183(17)210630(11)200630(10)922039;  922040 / (01)15099590693183(17)210731(11)200731(10)922040;  922062 / (01)15099590693183(17)210731(11)200731(10)922062;  922145 / (01)15099590693183(17)210831(11)200831(10)922145;  922146 / (01)15099590693183(17)210930(11)200930(10)922146;  922338 / (01)15099590693183(17)210930(11)200930(10)922338;  922440 / (01)15099590693183(17)211031(11)201031(10)922440;  922545 / (01)15099590693183(17)211031(11)201031(10)922545;  922547 / (01)15099590693183(17)211130(11)201130(10)922547;  922713 / (01)15099590693183(17)211231(11)201231(10)922713;  922714 / (01)15099590693183(17)211231(11)201231(10)922714;  922722 / (01)15099590693183(17)220131(11)210131(10)922722;  922897 / (01)15099590693183(17)220131(11)210131(10)922897;  124235 / (01)15099590693183(17)220228(11)210228(10)124235;  124339 / (01)15099590693183(17)220228(11)210228(10)124339;  922898 / (01)15099590693183(17)220228(11)210228(10)922898;  124340 / (01)15099590693183(17)220331(11)210331(10)124340;  124348 / (01)15099590693183(17)220430(11)210430(10)124348;  124353 / (01)15099590693183(17)220430(11)210430(10)124353;  124688 / (01)15099590693183(17)220430(11)210430(10)124688;  124354 / (01)15099590693183(17)220531(11)210531(10)124354;  124355 / (01)15099590693183(17)220630(11)210630(10)124355;  124356 / (01)15099590693183(17)220630(11)210630(10)124356;  124357 / (01)15099590693183(17)220630(11)210630(10)124357;",
      "more_code_info": ""
    }
  ]
}