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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01117-1
Product Name/Description	artus C. trachomatis Plus kits (used for the detection of plasmid free variants of Chlamydia trachomatis) artus C. trachomatis Plus RG PCR Kit (24) CE - Cat. No. 4559263 artus C. trachomatis Plus RG PCR Kit (96) CE - Cat. No. 4559265 artus C. trachomatis Plus LC PCR Kit (24) CE - Cat. No. 4559063 artus C. trachomatis Plus LC PCR Kit (96) CE - Cat. No. 4559065 artus C. trach. PLUS RG PCR Kit (768) CE - Cat. No. 4559267 An in vitro diagnostic medical device (IVD)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	16/11/2015
Responsible Entity	Qiagen Pty Ltd
Reason/Issue	The artus C. trachomatis Plus kits are designed to detect a 106 bp region of the Chlamydia trachomatis chromosome and a 111 pb region of the cryptic plasmid of C. trachomatis; however, the kits fail to detect the chromosomal target. The kits do not detect cryptic-plasmid-free variants. Accordingly, QIAGEN will be amending the Instructions for Use of this product to remove the claim that the product can detect cryptic-plasmid free variants of C. trachomatis.
Recall Action	Recall for Product Correction
Recall Action Instructions	QIAGEN is advising users to be aware that cryptic-plasmid-free variants of C. trachomatis are not detected by the kits. QIAGEN is advising a review of negative patient results is at the discretion of the Laboratory Manager. This action has been closed-out on 24/08/2016.
Contact Information	03 9840 9800 - QIAGEN