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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00342-1
Product Name/Description Streptex Group D Latex agglutination reagent R30950901, An in vitro diagnostic medical device (IVD)

Lot number: 1149576
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 19/04/2013
Responsible Entity Oxoid Australia Pty Ltd
Reason/Issue Investigations by the manufacturer have confirmed that latex reagent within this batch may give weak or false negative results. Continued use of this lot could result in false negative results with some cultures.
Recall Action Recall
Recall Action Instructions Oxoid is asking customers to destroy the affected reagents.
Contact Information 08 8238 9044 - Oxoid Australia Regulatory Affairs