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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00909-1
Product Name/Description Remel Xpect Clostridium difficile Toxin A/B. An vitro diagnostic medical device (IVD)

R24650 - Lot number: 131988

R24640 - Lot number: 141764
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 6/09/2012
Responsible Entity Oxoid Australia Pty Ltd
Reason/Issue Investigations have confirmed that some units of the reagents in these lots may contain microbial contamination that could impact assay procedure and/or performance.
Recall Action Recall
Recall Action Instructions Laboratories to inspect stock and remove from use any units from affected lot numbers. Previous results issued from these lots should be reviewed.
Contact Information 08 8238 9044 - Peter Traynor