| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00589-1 |
| Product Name/Description |
EZTest steam and Smart-Read EZTest steam Biological Indicators
Lot numbers: S-444, SR-444, S-445, SR-445, S-447
ARTG Number: 126974 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer determined that the read out time is not within specification of the label claims on these lots. There is potential for delayed or incomplete colour change (false fail) at the indicated incubation time of 10 hours. |
| Recall Action |
Recall |
| Recall Action Instructions |
Austmel are asking customer to return all unused products for replacement with unaffected stock. If affected stock must be used, Austmel is advising end users to incubate the exposed biological indicator for a minimum of 72 hours. |
| Contact Information |
1800 074 085 - Austmel Customer Service |