Recall of ABL800 FLEX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer America Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78445
  • Event Risk Class
    Class 2
  • Event Number
    Z-0231-2018
  • Event Initiated Date
    2017-10-24
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Reason
    Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient will be printed or displayed on the analyzer.
  • Action
    Customer were notified via letter using FedEx tracking on approximately October 24, 2017. Instructions included verification that the test results and the patient and demographic information matches, that Radiometer America is working to improve the software to remove the possibility of the code being misinterpreted, and to notify customers if the product has been further distributed. For further questions, please call (800) 736-0600.

Device

  • Model / Serial
    All serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (nationwide) to: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. Distributed internationally to Canada.
  • Product Description
    ABL800 analyzer with FLEXQ module. || Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of samples of expired air for the parameters pO2 and pCO2. It is also used for in vitro testing of pleura samples for the pH parameter
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Radiometer America Inc, 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
{"cc_re__cc_re__cc_by_sa_3_0": ["d patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.\n    </p>\n  </section>\n\n    <section class=\"sidebar__section\">\n      <h3 class=\"sidebar__section__heading\">\n        Download the data\n      </h3>\n      <p>\n        The International Medical Devices Database is licensed under the <a href=\"http://opendatacommons.org/licenses/odbl/1.0/\" target=\"_blank\">Open Database License</a> and its contents under <a href=\"http://creativecommons.org/licenses/by-sa/3.0/\" target=\"_blank\">Creative Commons Attribution-ShareAlike</a> license. Always cite the <a href=\"https://icij.org\" target=\"_blank\">International Consortium of Investigative Journalists</a> when using this data. You can download a raw copy of the database here.\n      </p>\n      <a class=\"btn btn-block btn-outline-primary text-primary\" href=\"/download/icij-imddb-2023-04-11.zip\">\n        <i class=\"fa fa-download mr-2\"></i>\n        Download all (zipped)\n</a>    </section>\n</aside>\n\n    </div>\n  </div>\n</div>\n\n    \n   "]}