| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00865-1 |
| Product Name/Description |
Oxoid Antimicrobial Susceptibility Discs with Augmentin (Amoxycillin and Clavulanic acid - AMC3). An in vitro diagnostic medical device (IVD)
Product code: CT0538B
Lot Number: 1183450 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
Investigations by the manufacturer have confirmed that cartridges within this batch may contain individual discs with insufficient amount of antibiotic, resulting in smaller than expected amounts of inhibition. Continued use of the affected lot could result in false indication of resistance to augmentin. |
| 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 - Oxoid Australia |