| 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 |
|
| 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 |