Events

Recall of Device Recall ABL80 FLEX Analyzer

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
    38172
  • Event Risk Class
    Class 2
  • Event Number
    Z-1196-2007
  • Event Initiated Date
    2007-03-27
  • Event Date Posted
    2007-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53095
  • 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 - Product Code CHL
  • Reason
    There have been reported experiences where waste fluids have sprayed out from the waste drain at the front of the abl80 analyzer when excessive pressure builds within the waste line.
  • Action
    The recall was initiated 3/27/2007. All distributors were notified via the Radiometer FAN (field action notice) system which provides a communication mechanism for these types of actions. The notice advises that there have been a few reported experiences where waste fluids have sprayed out from the waste drain at the front of the ABL80 analyzer which occurs when excessive pressure builds within the waste line. To prevent any spraying of fluids from the waste drain a check valve has been added to the waste tubing, between the waste drain and the waste pump which allows fluids to flow in one direction thus making it impossible to spray fluids out the waste drain. The letter further advises that all analyzers shipped from SenDx on or after March 16, 2007 will include this check valve. All analyzers already in the field must be updated to include this check valve. Distributors are to distribute a copy of the Customer Advisory Letter associated with this case to all their customers and update all ABL80 analyzers to include the waste drain check valve as per the instructions that accompany the check valve. The Advisory Letter informs the customer of the problem and the new waste drain check valve and provides precautionary instructions such as appropriate hand, eye, face and clothing shields. In addition, it advises that the analyzer should never be used if there is any indication of a waste drain occlusion or blockage. The most typical indication of an occlusion or blockage is fluid overflowing out of the waste drain.

Device

Device Recall ABL80 FLEX Analyzer
  • Model / Serial
    All analyzers produced between 10/26/06 to 3/15/07 are being recalled (serial code/lot code range of 300101 to 300517)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide Distribution --- USA including state of Ohio, and countries of Austria, Belgium, Denmark, Finland, France, Germany, Italy, Japan, The Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, New Zealand, Canada, and Denmark.
  • Product Description
    ABL80 FLEX Analyzer, Model #393-839
  • Manufacturer
    Sendx Medical Inc

Manufacturer

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