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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-01195-1
Product Name/Description	DR0850M, Oxoid Staphytect plus 100 tests (used for the identification of Staphlococcus aureus). An in vitro diagnostic medical device (IVD) Lot number: 1141522
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/11/2012
Responsible Entity	Thermo Fisher Scientific Australia & New Zealand
Reason/Issue	Investigations by the manufacturer have confirmed that test latex within this batch may present an atypical agglutination reaction resulting in a false positive interpretation. Continued use of this lot could result in false identification of Staphylococcus aureus.
Recall Action	Recall
Recall Action Instructions	Quarantine and remove affected units form use.
Contact Information	08 8238 9044 - Oxoid Australia Regulatory Affairs