{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Brea",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81490",
      "recalling_firm": "Radiometer America Inc",
      "address_1": "250 S Kraemer Blvd",
      "address_2": "",
      "postal_code": "92821-6232",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WA, WI, and WV    OUS:  Canada, Croatia, Finland and Russia",
      "recall_number": "Z-0801-2019",
      "product_description": "Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837.    ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845.",
      "product_quantity": "1619",
      "reason_for_recall": "From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on analyzers could be underestimated with up to 28% as compared with measurements from COBAS. The underestimated creatinine occurs specifically, when measurements on Autocheck 6+ level 1 (also known as S7835 Autocheck module and abbreviated AC6+L1) are less than or equal to 230 micro-meter of a specified insert interval for AC6+L1 with insert limits 210 290 micro-meter. Ultimately, a lower read-out on patient samples is observed    Customers are concerned about underestimation of creatinine results in patients, which are to undergo radiocontrast x-ray investigations. If these patients are not healthy, the exposure of radiocontrast agents may induce kidney insufficiency (contrast-induced nephropathy). Hazardous situation: Underestimation of the concentration of creatinine.",
      "recall_initiation_date": "20180702",
      "center_classification_date": "20190205",
      "termination_date": "20240402",
      "report_date": "20190213",
      "code_info": "Model  ABL817 FLEX  Serial Numbers:  754R2180N003  754R1920N003  754R1426N004  754R1468N002  754R1924N005  754R2504N015  754R2180N005    Model   ABL827 FLEX  Serial Numbers:  754R0700N002  754R2190N004  754R2442N006  754R2272N002  754R2272N004  754R1129N006  754R2348N001  754R2348N006  754R2435N007  754R1661N002  754R1661N004  754R2311N004  754R1003N003  754R1003N005  754R1422N004  754R1434N008  754R1099N004  754R1099N005  754R1907N006  754R1909N003  754R1909N006  754R2296N004  754R1172N006  754R2425N003  754R2425N004  754R2370N005  754R2370N006  754R1559N001  754R1559N003  754R1009N005  754R1009N006  754R1009N007  754R1010N006  754R1010N007  754R1011N001  754R2460N008  754R2460N009  754R2023N002  754R1011N006  754R1013N001  754R1870N001  754R1986N004  754R2150N006  754R2151N001  754R2162N003  754R2162N005  754R2442N008  754R2443N001  754R2443N004  754R1863N006  754R1333N003  754R2443N002  754R2443N003  754R1468N003  754R1468N004  754R2124N006  754R0832N007R  754R2196N007  754R1204N003  754R1462N008  754R2518N006  754R2521N005  754R2521N007  754R2521N011  754R1887N003  754R1887N006  754R1143N006  754R1143N007  754R1679N004  754R1159N001  754R1159N002  754R2363N004  754R2366N004  754R2367N002  754R2369N001  754R2369N002  754R2369N003  754R2058N002  754R2058N004  754R1766N008  754R1767N004  754R1768N001  754R1778N004  754R1778N008  754R1895N003  754R1907N001  754R1667N003  754R1001N004  754R1887N002  754R1864N003  754R1869N007  754R2347N006  754R0765N007  754R1669N006  754R2458N008  754R2458N009  754R2080N004  754R2080N007  754R2080N008  754R2081N001  754R2081N002  754R1829N007  754R1829N008  754R0512N008  754R1682N001  754R2459N013  754R2459N014  754R1220N004  754R1220N005  754R1561N004  754R1781N002  754R1049N005  754R2441N009  754R1148N003  754R1148N004  754R1817N006  754R1818N003  754R1829N003  754R2156N003  754R2156N004  754R2387N001  754R2387N003  754R2387N004  754R2459N015  754R2460N001  754R2475N007  754R2481N005  754R2481N006  754R2486N006  754R2486N007  754R2486N014  754R2489N006  754R2491N009  754R2491N013  754R2503N007  754R2503N008  754R2503N012  754R2504N018  754R2504N020  754R2530N014  754R2530N015  754R1403N007  754R0579N001  754R1759N003  754R2013N005  754R2013N006  754R1984N003  754R1985N002  754R2023N003  754R2412N003  754R2412N006  754R2218N002  754R2024N002  754R2366N003  754R2366N006  754R0574N001  754R0574N002  754R0574N004  754R1875N001  754R1876N007  754R2152N001  754R1404N001  754R1404N002  754R1404N003  754R2321N002  754R2062N010  754R2062N011  754R1682N002  754R2217N003  754R1336N006    Model   ABL837 FLEX  Serial Numbers:  754R0700N001  754R1267N008  754R2140N004  754R2147N004  754R1798N002  754R1301N006  754R1314N006  754R1011N002  754R1204N008  754R1413N008  754R1596N001  754R1777N005  754R1909N005  754R1909N008  754R1797N008  754R1798N001  754R2371N001  754R2371N003  754R2371N005  754R2408N007  754R2408N009  754R0796N007  754R1267N004  754R1267N009  754R0834N003  754R0897N005  754R0897N008  754R2460N005  754R1968N003  754R1704N008  754R1723N005  754R0555N007  754R1725N001  754R1725N003  754R1644N002  754R1644N007  754R1595N001  754R1600N003  754R0382N001  754R1964N003  754R0631N006U  754R0853N004  754R0896N005  754R1010N002  754R1010N003  754R1050N008  754R1051N002  754R1172N007  754R1173N006  754R1469N002  754R1831N005  754R1831N006  754R1948N006  754R1953N004  754R2223N002  754R2223N003  754R2429N008  754R2473N002  754R2473N004  754R2473N006  754R2473N007  754R2474N011  754R2474N012  754R2484N004  754R2503N010  754R2503N011  754R2504N009  754R2504N010  754R2504N012  754R2504N014  754R2519N005  754R2519N010  754R2519N011  754R2519N014  754R2100N005  754R1886N009  754R1887N005  754R2058N001  754R2058N005  754R1580N004  754R1580N005  754R1580N007  754R2429N009  754R0581N005  754R0079N007  754R0606N004  754R1051N003",
      "more_code_info": ""
    }
  ]
}