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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00506-1
Product Name/Description Oxoid Antimicrobial Susceptibility Testing Penicillin (P1) Discs (an in vitro diagnostic medical device (IVD))

Product Code: CT0152B

Lot Number: 1218658

Expiry: July 2015
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 5/05/2014
Responsible Entity Thermo Fisher Scientific Australia & New Zealand
Reason/Issue Investigations by the manufacturer Oxoid Limited, part of Thermo Fisher Scientific, have confirmed that cartridges within this batch may contain individual discs not impregnated with sufficient antibiotic. Continued use of this lot could result in false indication of resistance.
Recall Action Recall
Recall Action Instructions End users are requested 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.
Contact Information 08 8238 9044 - Thermofisher Scientific