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Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00214-1
Product Name/Description VITROS 5,1 FS Chemistry Systems using Software Version 2.8 & Below. An in vitro diagnostic medical device (IVD).

Product Codes: 6801375 & 6801890

ARTG Number: 180199
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/03/2015
Responsible Entity Ortho-Clinical Diagnostics
Reason/Issue Ortho-Clinical Diagnostics, Inc. (OCD) has confirmed two instances where a VITROS MicroSlide cartridge was misidentified. Both instances occurred when an operator accessed Slide Supply 1 (SS1) before the green indicator light was illuminated and subsequently proceeded to load a slide cartridge into Slide Supply 2. In each occurrence, the loaded cartridge in Slide Supply 2 was misidentified.
Recall Action Recall for Product Correction
Recall Action Instructions If an operator inadvertently accesses a Slide Supply load door before the green indicator light is illuminated and the system generates a TAS-70E or TAS-20E condition code the operator must open and close both Slide Supply doors (Slide Supply #1 & 2), not remove or add any cartridges, and initialise the system. This will cause the system software to scan all slots of both Slide Supplies in order to properly identify the contents.

Discuss any concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action.

The resolution to this issue will be contained in the next version of software currently under development. This action has been closed-out on 31/05/2016.
Contact Information 1800 032 359 - OCD Clinical Technical Services