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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00393-1
Product Name/Description Oxoid Antimicrobial Susceptibility Testing Discs - Ticarcillin/Clavulanic Acid (TIM85 Timetin). An in vitro diagnostic medical device (IVD).

Product Code: CT0449B

All lots affected

ARTG Number: 208273
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 5/04/2016
Responsible Entity Thermo Fisher Scientific Australia & New Zealand
Reason/Issue Internal investigations by Oxoid Limited have identified variability in concentration of certain lots of Timetin TIM85. Active compound degradation over the shelf life may result in lower than specified concentration leading to Out Of Specification performance results (small zone size).
Continued use of this product could result in delayed or false resistance reporting.
Recall Action Recall
Recall Action Instructions Thermo Fisher Scientific is advising users to inspect stock and remove any remaining stocks of the affected product from use. Please complete the reply form and return in order for a credit note to be issued.
Action closed out on 21/08/2018
Contact Information 08 8238 9044 - Oxoid Austalia