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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01118-1
Product Name/Description VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. An in vitro diagnostic medical device (IVD)

GLU Slides
Product Code: 1707801
Current/In-date Generations (GENs): 10, 11, 20 through 31

LAC Slides
Product Codes: 8433880, 8150112
Current/In-date GENs: 30, 31

TRIG Slides
Product Codes: 1336544, 8329930
Current/In-date GENs: 16, 17, 19, 20, 22, 23, 24, 25, 27 through 32

URIC Slides
Product Code: 1943927
Current/In-date GENs: 26, 27, 28, 29, 31

ARTG Number: 232248
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 25/08/2016
Responsible Entity Ortho-Clinical Diagnostics
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.

This action has been closed out on 01/11/2018
Contact Information 1800 032 359 - Ortho Care Technical Solutions Centre