Events

Recall of Dimension Creatinine (CRE2) Flex reagent cartridge (Used with Dimension clinical chemistry system). 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-2016-RN-00807-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00807-1
  • 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 healthcare diagnostics has identified that dimension creatinine (cre2) assay exhibits a negative bias at the low end of the urine analytical measurement range (amr). the limit of quantitation (loq) claim 442 µmol/l for urine samples is not met. this issue affects all future lots of cre2 until a solution is implemented. the serum/plasma cre2 amr is not affected by this issue.The bias observed for urine creatinine samples < 1149 ìmol/l would not impact clinical interpretation of adult egfr calculations or clinical interpretation of laboratory tests utilising creatinine as a correction factor, such as urine albumin/creatinine ratio and/or urine protein/creatinine ratio.
  • Action
    Siemens is advising users to review the maximum observed bias for low urine concentrations. It is recommended that urine CRE2 values that are less than 1149umol/L are reported as <1149umol/L rather than an actual numeric results. Siemens is providing work around instructions for users to change the lower assay range parameters to 1149umol/L. Siemens is not recommending a review of previously generated results, however a review is at the discretion of the laboratory.

Device

Dimension Creatinine (CRE2) Flex reagent cartridge (Used with Dimension clinical chemistry system...
  • Model / Serial
    Dimension Creatinine (CRE2) Flex reagent cartridge (Used with Dimension clinical chemistry system). An in vitro diagnostic medical device (IVD)Catalogue Number: DF33BSiemens Material Number: 10872079All lot numbers affectedARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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