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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00159-1
Product Name/Description	Oxoid Xpect Legionella Test Kit (R24680), an in vitro diagnostic medical device (IVD) Lot number 249258
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	20/02/2013
Responsible Entity	Thermo Fisher Scientific Australia & New Zealand
Reason/Issue	Investigations by the manufacturer have confirmed that cassettes within this lot of Oxoid Xpect Legionella Test Kit may produce false positive results. Continued use of this lot could result in the false reporting of the presence of Legionella pneumophila serogroup 1 and 6 antigens in human urine samples.
Recall Action	Recall
Recall Action Instructions	Thermo Fisher Scientific is requesting their customer to inspect their stock and quarantine any affected units. Upon confirmation of affected stock Thermo Fisher Scientific will provide a credit note.
Contact Information	08 8238 9044 - Oxoid Australia Regulatory Affairs