Events

Recall of Device Recall ABL90 FLEX analyzer

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
    70103
  • Event Risk Class
    Class 2
  • Event Number
    Z-1046-2015
  • Event Initiated Date
    2014-12-08
  • Event Date Posted
    2015-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132250
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • Reason
    The abl90 analyzer does not always use the most recent calibration data to calculate patient results. this can in some cases lead to a biased patient result.
  • Action
    Radiometer sent a Field Safety Notice dated December 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. What you should do short term: " Please ensure that the operator always closes the inlet when prompted by the analyzer, as per the labeling. " In case the inlet, by mistake, is not closed as per the labeling, please ensure that the following is carried out before measuring a patient sample: " Close the inlet and wait for the analyzer to go to READY (approximately five minutes) " Open the inlet and then close again (to initiate a Rinse) " Wait for the analyzer to go to READY (approximately 1¿ minutes) " Please return the confirmation fax form no. 1 to your RADIOMETER representative when the above actions have been implemented Final Solution provided by RADIOMETER: A mechanism will be provided in an upgraded version of the analyzer software to eliminate the possibility of this error. The new software version will be installed by your local engineer when available. Customers were instructed to ensure that this letter is distributed to the final end-user. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, opt 4.

Device

Device Recall ABL90 FLEX analyzer
  • Model / Serial
    Model number 393-090 (instrument).  The affected analyzers are serial numbers 393-090R0027N001 to present.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -USA including CT, MN, FL, CA, PA, NY, KY, MA, WA, MI, TX, NC, IL, OH, SC, OK, NJ, MD, VA, UT, AL, NM, GA, LA, OR, IN, WI, AZ, ND, CO, MO, WV, ID, TN, VT, NE, IA, NH, MS, ME, AR and Internationally to Canada, Australia, Austria , China, Czech Republic, Denmark, Estonia, Lithuania, Romania, Slovenia, United Arab Emirates, Bolivia, Brazil, Indonesia, Israel, Kuwait, Malaysia, Mexico, Peru, Qatar, Saudi Arabia, Serbia and Montenegro, Syrian Arab Republic, Thailand, Vietnam, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Republic of Korea, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
  • Product Description
    ABL90 FLEX analyzer; Model number 393-090. 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