Events

Recall of Chemistry 1 Calibrator (used with the Dimension Vista 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-01243-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01243-1
  • 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 affected lots may produce depressed results with current lots of calcium reagent. although the affected lots are expired, the calcium calibration interval is 90 days; therefore, it is possible that calibrations using the affected calibrator lots are active. average bias for current calcium (ca) reagent lots ranges from -0.08 mmol/l to -0.2 mmol/l with a maximum individual sample bias of -0.3 mmol/l. biases were calculated based on the differences observed when comparing to results generated using nist standard material for calibration. biases were similar for urine and serum samples and were not dependent upon calcium concentration. when this issue occurs, the potential exists for misinterpretation of calcium levels, which may affect consideration of intervention.
  • Action
    Siemens is advising user that if they have an active calibration of Calcium (CA) that used calibrator lot 5GM081 or 5GM082, recalibrate CA with an alternate lot of CHEM 1 CAL. Siemens is not recommending a review of previously generated results.

Device

Chemistry 1 Calibrator (used with the Dimension Vista System). An in vitro diagnostic medical dev...
  • Model / Serial
    Chemistry 1 Calibrator (used with the Dimension Vista System). An in vitro diagnostic medical device (IVD)Catalogue Numbers: KC110, KC110BSiemens Material Numbers: 10445169, 10716281Lot Numbers: 5GM081, 5GM082Expiry: 1 July 2016ARTG Number: 182222
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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