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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01115-1
Product Name/Description	Oxoid Antimicrobial Susceptibility Testing Disc - Ceftazidime CAZ10. An in vitro diagnostic medical device (IVD) Product Code: CT1629B Lot Number: 1426486 ARTG Number: 208273
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	24/08/2016
Responsible Entity	Thermo Fisher Scientific Australia & New Zealand
Reason/Issue	Investigation by Oxoid has identified that a single lot of Oxoid Antimicrobial Susceptibility Testing Disc Ceftazidime may contain discs with a reduced concentration of antibiotic, which may impact on performance. Testing with Pseudomonas aeruginosa ATCC 27853 (EUCAST quality control organism) returned lower than specified zones of inhibition. Continued use of this lot could result in quality control failures, delayed results or incorrect results reporting (false resistance).
Recall Action	Recall
Recall Action Instructions	Thermo Fisher is advising users to inspect their stock for affected units. Affected units are to be removed from further use. The requirement for the review of patient results should be determined by the laboratory director. This action has been closed-out on 11/05/2017.
Contact Information	08 8238 9044 - Thermo Fisher Scientific