Events

Recall of DIMENSION XPAND SYSTEM - AMMONIA (AMM) ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

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
    101639
  • Event Risk Class
    III
  • Event Initiated Date
    2017-03-07
  • 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
    In september 2014 siemens healthcare diagnostics issued customer notification 14-62 that addressed a high rate of "abnormal assay" test report messages for its dimension ammonia (amm) assay. with this letter siemens is reducing the amm open well stability from 3 days to 1 day (24 hours) and providing instructions for managing this change. dimension amm ifu revision e will reflect this change. the new version of dimension software 10.2 will do the following: -automatically move to a new well every day. this decrease in the open well maximum duration reduces the amount of time the amm reagent is exposed to any potential contaminates reduces the need for customers to manually move to a new reagent well and aids in the prevention of erroneous flagging. -contain the below mean factor limit of 0.90. siemens is working to make dimension software10.2 available to all customers as quickly as possible.

Device

DIMENSION XPAND SYSTEM - AMMONIA (AMM) ASSAY
  • Model / Serial
    Model Catalog: 10711991 (Lot serial: ALL); Model Catalog: DF119 (Lot serial: ALL)
  • Product Description
    DIMENSION XPAND SYSTEM-AMMONIA (AMM) ASSAY;DIMENSION EXL SYSTEM-AMMONIA (AMM) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC