Events

Recall of VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH results generated on VITROS 4600 Chemistry System, VITROS 5600 Integrated System and VITROS 5,1 FS Chemistry System

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-2014-RN-00502-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00502-1
  • 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
    This recall action has been initiated by ortho-clinical diagnostics, inc. (ocd) due to the potential for biased results when a multiple window (mw) code is associated with results generated by the vitros® systems listed. a mw code is a flag/error code generated when a potential issue with the results calculation is detected. this code does not suppress the sample result. a mw code is a flag/error code generated when a potential issue with the results calculation is detected. this code does not suppress the sample result.
  • Action
    Ortho-Clinical Diagnostics (OCD) will resolve this issue in a future software release. To assist in the interim OCD is providing a procedure for reviewing VITROS chemistry results and MW codes. This action has been closed-out on 11/02/2016.

Device

VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH results generated on VITROS 4600 Chemistry System, VI...
  • Model / Serial
    VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH results generated on VITROS 4600 Chemistry System, VITROS 5600 Integrated System and VITROS 5,1 FS Chemistry SystemVITROS 4600 Chemistry SystemProduct Code: 6802445Affected Software Versions: 3.0 and lowerVITROS 5600 Integrated SystemProduct Code: 6802413Affected Software Versions: 3.0 and lowerVITROS 5,1 FS Chemistry SystemProduct Codes: 6801375, 6801890Affected Software Versions: 2.7 and lowerMultiple assays affected
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics