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
    78105
  • Event Risk Class
    III
  • Event Initiated Date
    2016-12-23
  • 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
    Siemens has determined that five (5) lots of dimension ammonia assay (df119) and three (3) lots of dimension vista ammonia assay (k3119) flex reagent cartridges do not meet the 60-day calibration interval claim due to reagent instability and may show an abnormal assay message. these lots may exhibit accuracy shifts for patient and/or quality control results. this may cause laboratories to recalibrate more frequently than the 60-day claim in the ifu.

Device

DIMENSION XPAND SYSTEM - AMMONIA (AMM) ASSAY
  • Model / Serial
    Model Catalog: DF119 (Lot serial: BA7250); Model Catalog: 10711991 (Lot serial: FB7152); Model Catalog: DF119 (Lot serial: EA7223); Model Catalog: 10711991 (Lot serial: EA7223); Model Catalog: DF119 (Lot serial: BA7194); Model Catalog: 10711991 (Lot serial: BA7194); Model Catalog: DF119 (Lot serial: EB7180); Model Catalog: 10711991 (Lot serial: EB7180); Model Catalog: DF119 (Lot serial: FB7152); Model Catalog: 10711992 (Lot serial: 16265AB); Model Catalog: K3119 (Lot serial: 16265AB); Model Catalog: 10711992 (Lot serial: 16225BB); Model Catalog: K3119 (Lot serial: 16225BB); Model Catalog: 10711992 (Lot serial: 16187BE); Model Catalog: K3119 (Lot serial: 16187BE); Model Catalog: 10711991 (Lot serial: BA7250)
  • Product Description
    DIMENSION XPAND SYSTEM - AMMONIA ASSAY;DIMENSION EXL SYSTEM - AMMONIA ASSAY;DIMENSION CLINICAL CHEMISTRY- AMM ASSAY;DIMENSION VISTA SYSTEM - AMMONIA ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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