Events

Recall of ABL90 FLEX Analyzer Radiometer Medical ApS

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
    66875
  • Event Risk Class
    Class 2
  • Event Number
    Z-0816-2014
  • Event Initiated Date
    2013-10-15
  • Event Date Posted
    2014-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123921
  • 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, ion specific, sodium - Product Code JGS
  • Reason
    Radiometer become aware that if the abl90 flex is tilted, this may potentially cause a negative bias on sodium (na+) results.
  • Action
    Radiometer sent an Urgent Medical Device Recall letter dated November 5, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check all of their ABL90 FLEX analyzers and ensure that the analyzer is placed on a horizontal platform/table. If the analyzer is placed on a roll stand, please ensure that the support plate is aligned horizontally and locked in this position. Customers were asked to complete and fax the accompanying acknowledgment form in order to confirm their receipt of this field safety notice. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, option 4. For questions regarding this recall call 440-871-8900.

Device

ABL90 FLEX Analyzer Radiometer Medical ApS
  • Model / Serial
    Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & United Kingdom.
  • Product Description
    ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 || Br¿nsh¿j, Denmark || A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Manufacturer Address
    Radiometer America Inc, 810 Sharon Dr, Westlake OH 44145-1521
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA