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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00004-1
Product Name/Description VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)

Unique Device Identifier Number: 10758750004812

Product Code: 8379034

Generation (GEN): 1 through 6, 30 through 40, 44 through 49

Expiry Dates: 01 Jan 2017 through 01 Jun 2018

ARTG Number: 232249
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 4/01/2017
Responsible Entity Ortho-Clinical Diagnostics Australia Pty Ltd
Reason/Issue An issue has been identified where there is a potential for biased results to be generated over the 10 day on-analyzer limit when using VITROS Na+ Slide cartridges warmed between 1½ to 8 hours prior to being placed on the analyser. It has been determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyser storage limit. This issue affects all expired, in-date GENs, and future product until further notice.
Recall Action Recall for Product Correction
Recall Action Instructions Ortho Clinical Diagnostics is advising customers to store cartridges at room temperature for a minimum of eight (8) hours prior to calibration. Customers who have discarded cartridges will have their account credited or be sent a replacement.

This action has been closed out on 27/09/2018
Contact Information 1800 032 359 - Ortho Care Technical Solutions Centre