Events

Recall of Device Recall pH Blood Gas and Electrolytes Analyzer System

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
    60514
  • Event Risk Class
    Class 2
  • Event Number
    Z-2304-2012
  • Event Initiated Date
    2012-06-06
  • Event Date Posted
    2012-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111641
  • 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
    The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.
  • Action
    Radiometer sent a Field Safety Notice letter dated June 06, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. Also included is a Note to Users to be placed at the front of customers existing Operator's Manual. Customers were instructed to provide confirmation to Radiometer that all customers have received the letter and the Note to Users. For questions contact your Radiometer representative.

Device

Device Recall pH Blood Gas and Electrolytes Analyzer System
  • Model / Serial
    Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including the state of OH.
  • Product Description
    ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. || Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.
  • Manufacturer
    Sendx Medical Inc

Manufacturer

Sendx Medical Inc
  • Manufacturer Address
    Sendx Medical Inc, 1945 Palomar Oaks Way, Carlsbad CA 92011-1300
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA