Events

Recall of DIMENSION CHEMISTRY WASH

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
    63778
  • Event Risk Class
    II
  • Event Initiated Date
    2013-05-17
  • 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 healthcare diagnostics has received complaints of chemistry wash causing qc and patient sample result shifts on ctni ltni ft4 tsh pbnp and lpbn when using chemistry wash lots rd23031 rd23111 rd23241 rd23311 rd23391 and rd23461. these lots shipped between 12/12/2012 and 3/22/2013. internal investigation has confirmed shifts can be encountered in two scenarios: 1. when an affected lot of chemistry wash is placed on the instrument following an unaffected lot a negative bias will be seen on ctni ltni tsh pbnp and lpbn. a positive bias will be seen on ft4. 2. if any of these assays are calibrated using an affected lot of chemistry wash qc should return within range but when a subsequent unaffected chemistry wash lot is placed into use a positive bias will be seen on ctni ltni tsh pbnp and lpbn. a negative bias will be seen on ft4.

Device

DIMENSION CHEMISTRY WASH
  • Model / Serial
    Model Catalog: 10445052 (Lot serial: RD23031); Model Catalog: 10445052 (Lot serial: RD23111); Model Catalog: RD701 (Lot serial: RD23241); Model Catalog: 10445052 (Lot serial: RD23241); Model Catalog: RD701 (Lot serial: RD23311); Model Catalog: RD701 (Lot serial: RD23031); Model Catalog: RD701 (Lot serial: RD23391); Model Catalog: 10445052 (Lot serial: RD23391); Model Catalog: RD701 (Lot serial: RD23461); Model Catalog: 10445052 (Lot serial: RD23461); Model Catalog: RD701 (Lot serial: RD23111); Model Catalog: 10445052 (Lot serial: RD23311)
  • Product Description
    DIMENSION CHEMISTRY WASH
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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