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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01149-1
Product Name/Description	Coxiella burnetii IFA IgG Kit Reference Number: PCOBUG Kit Lot Number: 15C304 Slide Lot Number: 15C403 ARTG Number: 212957 An in vitro diagnostic medical device (IVD)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	8/09/2016
Responsible Entity	Abacus ALS Pty Ltd
Reason/Issue	Some Coxiella burnetii IFA IgG slides in kits from lot number 15C403 are labelled “Leishmania infantum” instead of “Coxiella burnetii”. The affected slides, while showing the inscription Leishmania infantum, are coated with Coxiella burnetii antigen and have the same features and performance as the slides labelled correctly with the Coxiella burnetii inscription. Of the slides checked by Vircell, only 0.3% present with this labelling anomaly.
Recall Action	Recall
Recall Action Instructions	Abacus ALS is advising users to cease use of stock with the affected lot number. Abacus will replace affected stock with unaffected stock. A look back of previous results is at the discretion of the laboratory director. This action has been closed out on 13 Jun 2017.
Contact Information	1800 222 287 - Abacus ALS