Events

Recall of PROT 1 CAL and PROT 1 CON when used with Dimension Vista CER Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty Ltd.

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
    RC-2017-RN-00678-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00678-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Siemens has confirmed a negative bias of approximately -20% for results obtained with dimension vista cer flex reagent cartridge when calibrating cer with specific prot 1 cal lots. prot 1 controls for cer are similarly biased. a deviation in the value assignment of the affected calibrators and controls is leading to a lower result compared to correctly assigned calibrators. patient samples with a true ceruloplasmin value of up to +20% above the lower end of the reference interval may be incorrectly found below the reference interval.
  • Action
    Siemens has assigned correct values to those lots of calibrators and controls where sufficient material was available for a new value assignment. Siemens is providing users with the correct values for these lots and advising users that these lots can be used for determination of ceruloplasmin with the revised assigned values and acceptance ranges. Lots for which revised values have not been provided are not to be used for ceruloplasmin measurements. The customer letter is to be reviewed with the laboratory Medical Director.

Device

PROT 1 CAL and PROT 1 CON when used with Dimension Vista CER Flex Reagent Cartridge. An in vitro ...
  • Model / Serial
    PROT 1 CAL and PROT 1 CON when used with Dimension Vista CER Flex Reagent Cartridge. An in vitro diagnostic medical device (IVD)PROT 1 CALProduct Code: KC710SMN: 10469516PROT 1 CON LProduct Code: KC715SMN: 10445919PROT 1 CON MProduct Code: KC716SMN: 10445920PROT 1 CON HProduct Code: KC717SMN: 10445921Multiple Lot NumbersARTG Number: 178153
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA