Events

Recall of SYNCHRON LX20 SYSTEM ANALYZER - CLASS 2

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BECKMAN COULTER CANADA L.P..

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
    63677
  • Event Risk Class
    II
  • Event Initiated Date
    2011-04-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Beckman coulter inc. has confirmed the following maintenance-related hardware issues can cause or contribute to erroneous electrolyte results on the synchron lxr20 synchron lxr20 pro and synchron lxri 725 clinical systems: 1. ratio pump wear 2. silver iodide build-up on the chloride electrode which if not removed may affect chloride performance and shorten the usable life of the electrode and 3. microbial contamination introduced into the system via the deionized water source reagent straws or other external sources. the use of incompatible bleach and saline products for the twice-weekly flow cell cleaning procedure may introduce electrolyte instability in the synchron lx20 system.

Device

SYNCHRON LX20 SYSTEM ANALYZER - CLASS 2
  • Model / Serial
    Model Catalog: 466002 (Lot serial: ALL); Model Catalog: 476100 (Lot serial: ALL); Model Catalog: 476501 (Lot serial: ALL)
  • Product Description
    SYNCHRON LX20 SYSTEM ANALYZER - CLASS 2
  • Manufacturer
    BECKMAN COULTER CANADA L.P.

Manufacturer

BECKMAN COULTER CANADA L.P.