Events

Recall of Device Recall ABL8O FLEX

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sendx Medical 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
    38350
  • Event Risk Class
    Class 2
  • Event Number
    Z-1201-2007
  • Event Initiated Date
    2007-06-04
  • Event Date Posted
    2007-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53470
  • 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
    in vitro diagnostic analyzer software - Product Code CHL
  • Reason
    The abl8o flex software version 1.10 contains errors in the derived parameter calculation for cbase(b,ox) and cbase(ecf,ox). these incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. elevated hemoglobin concentrations have the greatest impact on this calculation err.
  • Action
    A total of eight (8) distributors and the Radiometer main office in Denmark were sent the recall package (Field Action Notice) by email on 6-6-07. The distributors were provided background information and specific instruction on the steps to perform to correct the problem. The Recall package included a Management Cover for Field Action Notes and the Field Action Notice. Radiometer has released a subsequent software upgrade (v.1.11) to correct the two problems noted in the Recall Notice.

Device

Device Recall ABL8O FLEX
  • Model / Serial
    Software Version 1.10 Lot numbers: 17293, 17384, 17440, 17515, 17572 and 17663.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    In US to Cleveland, OH and Worldwide to Belgium, Denmark, France, Germany, The Netherlands, Sweden & United Kingdom
  • Product Description
    ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863
  • Manufacturer
    Sendx Medical Inc

Manufacturer

Sendx Medical Inc
  • Manufacturer Address
    Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92009-1307
  • Source
    USFDA