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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00445-1
Product Name/Description CT0003B AMP10 Ampicillin Antimicrobial Susceptibility Testing Discs. An in vitro diagnostic medical device (IVD)

Product code: CT0003B

Lot number: 1106822
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 21/05/2013
Responsible Entity Oxoid Australia Pty Ltd
Reason/Issue Investigations have confirmed that cartridges within this batch may contain individual discs not impregnated with antibiotic. Continued use of this lot could result in false indication of resistance to ampicillin.
Recall Action Recall
Recall Action Instructions Customers are requested to inspect their stock and quarantine any affected units. The requirement for review of patient results should be determined by the laboratory director.
Contact Information 08 8238 9044 - Oxoid Regulatory and Technical Manager