Events

Recall of ADVIA Centaur Folate ReadyPack, Lot 071218 Kit Lots (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 Ltd Diagnostics Division.

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-2013-RN-00778-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00778-1
  • 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 that a portion of folate readypacks in kit lots ending in 218 are exhibiting calibration failures and/or significant negative shifts in quality control (qc) and patient results. if the calibration and qc on a readypack are valid, results generated with this readypack are not affected. however, due to the sporadic nature of the issue, successful calibration and qc on one readypack may not reflect acceptable performance of other readypacks in the lot.
  • Action
    If a customer has an alternative method or lot of ADVIA Centaur Folate, Siemens Healthcare is advising users to transition all folate testing to the alternative lot or method. Siemens Healthcare is providing users with work around instructions to follow with the affected product. The Laboratory Medical Director should determine if repeat testing of patient samples that demonstrated results below the reference interval is appropriate.

Device

ADVIA Centaur Folate ReadyPack, Lot 071218 Kit Lots (an in vitro diagnostic medical device (IVD))
  • Model / Serial
    ADVIA Centaur Folate ReadyPack, Lot 071218 Kit Lots (an in vitro diagnostic medical device (IVD))ADVIA Centaur Folate (100 tests)Kit Lot Numbers: 22288218, 22296218 & 22907218ADVIA Centaur Folate (500 tests)Kit Lot Numbers: 22289218, 22297218 & 22535218ADVIA Centaur Folate (500 tests)Kit Lot Number: 22298218ADVIA Centaur Folate (2500 tests)Kit Lot Number: 22299218Expiration Date: 17 Feb 2014ARTG Number:175700
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA