| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01024-1 |
| Product Name/Description |
Oxoid M.I.C Evaluator for Penicillin 256 microgram/ml
Catalogue Number: MA0101D/F
Lot Number: 1708082
ARTG Number: 208273 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
A technical investigation has confirmed that the affected lot contains insufficient concentration of penicillin. Continued use of this product could result in the incorrect reporting of Minimum Inhibitory Concentration against penicillin. |
| Recall Action |
Recall |
| Recall Action Instructions |
Thermo Fisher is advising users to inspect stocks and remove from use any remaining units of the affected lot number. Affected stock can be returned or destroyed for credit.
Results issued with the affected lot number should be reviewed against case histories, other results and other relevant individual data. This action has been closed-out on 25/08/2016. |
| Contact Information |
08 8238 9081 - Thermo Fisher Australia & New Zealand |