Events

Recall of VITROS Immunodiagnostic Products CK-MB Calibrators. 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 Ortho-Clinical Diagnostics.

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-00367-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00367-1
  • 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
    Ortho clinical diagnostics has revised the storage instructions for vitros immunodiagnostic products ck-mb calibrators. internal testing demonstrated that opened-reconstituted vitros ck-mb calibrators stored at -20degc generated invalid calibrations that were detected by positively biased quality control results.
  • Action
    OCD is updating the instructions for use to reflect that refrigerated storage at 2-8 degrees centigrade is acceptable. OCD is asking users to discontinue use of units stored at -20 degrees centigrade. This action has been closed-out on 11/02/2016.

Device

VITROS Immunodiagnostic Products CK-MB Calibrators. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    VITROS Immunodiagnostic Products CK-MB Calibrators. An in vitro diagnostic medical device (IVD)Product Code: 1286293
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics