| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00086-1 |
| Product Name/Description |
VaccZyme Anti-Haemophilus Influenzae B
Kit Code: MK016
Lot Numbers: 341492, 347294 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
10/02/2015 |
| Responsible Entity |
|
| Reason/Issue |
Possible visible and/or sub-visible microbial contamination of sample diluent was identified following a customer notification. Internal testing has shown filtration of sample diluent using a 0.2 micron filter does not cause any significant change in performance of the diluent and therefore may be employed by the customer. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Internal testing by The Binding Site has shown that filtration of the sample diluent using a 0.2 micron filter does not cause any significant change in the performance of the diluent and therefore may be employed by the customer to remove the physical matter that may be present.
It is strongly recommended that the filter and any alternative receptacles used are both as clean as possible in order to prevent any further potential for contamination of the product. This action has been closed-out on 03/08/2016. |
| Contact Information |
1300 552 003 - In Vitro Technologies Customer Care |