| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00689-1 |
| Product Name/Description |
CT0003B AMP10 Ampicillin Antimicrobial Susceptibility Testing Discs (An in vitro diagnostic medical device (IVD))
Lot Number: 1071623 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/07/2013 |
| Responsible Entity |
|
| Reason/Issue |
Investigations by the manufacturer have confirmed that cartridges within the affected 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 |
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 - Thermo Fisher Scientific |