Events

Recall of VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. 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-2016-RN-01118-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-08-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01118-1
  • 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
    1. ortho clinical diagnostics (ortho) was made aware of new information regarding the potential for n-acetylcysteine (nac) to interfere with specific vitros chemistry products slide assays (glu, lac, trig and uric). patients who were administered nac could potentially have biased sample results. 2. ortho has also found that dextran 40 and glutathione may also interfere with vitros glu slides and cause biased results.To date, ortho is not aware of any misreported patient results associated with this issue all expired, current/in-date and future generations (gens) of the assays are affected.
  • Action
    The Instructions for Use (IFUs) for the affected assays (GLU, LAC, TRIG, URIC) will be revised to include the interferent information in the Limitations of the Procedure section. Ortho is advising users that biased results may occur for patient sample containing these substances and is providing the results of the interference testing undertaken with these substances. The affected VITROS Slide Assays can continue to be used, with consideration of the new potential interferents. Any concerns regarding previously reported results should be discussed with the Laboratory Medical Director to determine the appropriate course of action.

Device

VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. An in vitro diagnostic medical dev...
  • Model / Serial
    VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. An in vitro diagnostic medical device (IVD)GLU SlidesProduct Code: 1707801Current/In-date Generations (GENs): 10, 11, 20 through 31LAC SlidesProduct Codes: 8433880, 8150112Current/In-date GENs: 30, 31TRIG SlidesProduct Codes: 1336544, 8329930Current/In-date GENs: 16, 17, 19, 20, 22, 23, 24, 25, 27 through 32URIC SlidesProduct Code: 1943927Current/In-date GENs: 26, 27, 28, 29, 31ARTG Number: 232248
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics