VITROS Chemistry Products Slide Assays - GLU, LAC, TRIG, URIC. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2016-RN-01118-1

Class II

2016-08-25

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01118-1

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.

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.