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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-01246-1
Product Name/Description Oxoid Anti-microbial Susceptibility Testing Disc for Nitrofurantoin. An in vitro diagnostic medical device (IVD)

F200 (Nitrofurantoin)
Lots 1194943

F300 (Nitrofurantoin)
Lots 1191121

An in vitro diagnostic medical device (IVD)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 10/12/2012
Responsible Entity Oxoid Australia Pty Ltd
Reason/Issue A technical investigation has indicated that cartridges of the affected lots may present atypical results. Continued use could result in a false indication of sensitivity to Nitrofurantoin.
Recall Action Recall
Recall Action Instructions Return affected lots to Oxoid Australia for replacement with unaffected stock.
Contact Information 08 8238 9044 - Oxoid Australia Regulatory Affairs