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
    76339
  • Event Risk Class
    Class 2
  • Event Number
    Z-1462-2017
  • Event Initiated Date
    2017-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152859
  • 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
    Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
  • Action
    Customer notification letters were sent 01/27/16. The letter provided the following instructions: The firm recommends that customers ensure that operators and clinicians using the "cord blood sample results from a HIS/LIS or a middleware system to determine treatment are made aware that arterial or venous is not transmitted. An upgraded version of the ABL90 and ABL800 series software will ensure that the full sample type cord blood arterial and cord blood venous will be transmitted to the HIS/LIS or middleware system. The new software version will be installed by local engineer when available. If not the end user customers are instruction to provide a copy of the recall notification letter to the end user. Any questions regarding this letter contact Radiometer America Technical Support at 1-800-736-0600 opt.1.

Device

Device Recall ABL90 Flex
  • Model / Serial
    The affected analyzers are serial numbers 393-090R0027N001 to present.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. distribution to the following; nationwide. Foreign distribution to the following; Netherlands, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.
  • Product Description
    ABL90 Flex || Model #: 393-090 || 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, 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA