Events

Recall of Device Recall ABL90 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
    58273
  • Event Risk Class
    Class 2
  • Event Number
    Z-2112-2011
  • Event Initiated Date
    2011-01-12
  • Event Date Posted
    2011-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98848
  • 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, potassium - Product Code CEM
  • Reason
    Following the receipt of two (2) reported customer complaints, the firm determined that the current operating software for their abl 90 analyzer does not prevent the further use of the sensor cassette when there is the possibility of iron rich plaque build-up in the reference electrode. if the device operator/user ignores the error message and continues to obtain biased measuring results using the.
  • Action
    The firm, Radiometer America, sent two Urgent "Medical Device Field Correction" letters issued on February 4, and on February 24th, 2011. The letters described the product, problem and actions to be taken. The customers were instructed to replace the sensor cassette. In order to prevent this situation from occurring, the firm informed the customers in the recall/correction notification that they intend to upgrade all ABL 90 Flex analyzers to a new software version. The new software will perform a check during a normal system FLUSH in order to allow the analyzer to detect the bias and will notify the customer immediately of this condition and will automatically disable the cassette thus preventing further use. The letter goes on to remind the device customers that until such time as the software upgrade is installed, they should make sure to adhere to the procedures stated in the Reference Manual which call for the replacement of the sensor cassette immediately upon receiving message #1310. The letter further instructs the customer to complete and return the attached FAX RETURN FORM via fax to 440-871-0463. The letter also states that the expected release date for the new software should be sometime in the second half of February 2011. If you have any questions regarding this letter, or the upgrade, please contact Technical Support staff at 1-800-736-0600 Opt 4.

Device

Device Recall ABL90 FLEX
  • Model / Serial
    Part Number: 393-090, all production runs for Serial Numbers: 393-090R0026N0010 to 393-090R0082N0005.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of CA, DC, PA, MN, NY, NJ, TX, OH, MO, WI, UT, and MI; and country of Canada.
  • Product Description
    ABL90 FLEX Portable Blood Gas Analyzer System, Part Number: 393-090, 510 (k) #K092686. All units equipped with software versions: 2.4.1680.25 and all previous versions are subject to recall. || The ABL90 FLEX is a portable, automated analyzer that measures pH, blood Gases, electrolytes, glucose, lactate and oximetry in whole blood. The ABL90 FLEX is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
  • Manufacturer
    Radiometer America Inc

Manufacturer

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