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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01097-1
Product Name/Description	CEDIA Tobramycin II Assay(used for quantitative determination of tobramycin in human serum or plasma) (an in vitro diagnostic medical device (IVD)) Lot Number: 60169764
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	24/10/2013
Responsible Entity	Thermo Fisher Scientific
Reason/Issue	In-house testing of the CEDIA Tobramycin II Assay (LN: 60169764) shows that the reconstituted reagents do not maintain 30 days reconstituted stability. The instability of the reconstituted reagents may cause higher recovery of samples. Hence, lot number 60169764 reagents must be used within 14 days after reconstitution. Reconstituted reagents beyond the 14 days should be discontinued and discarded.
Recall Action	Recall for Product Correction
Recall Action Instructions	Thermo Fisher is advising users to discard the affected lot 14 days after reconstitution. Thermo Fisher is advising users to inform the requesting physician of any change in assay performance and review patient results.
Contact Information	02 8817 4294 - Thermo Fisher Scientific Australia